Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-247: ISO 11990-1 First edition 2011-08-01, Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft. (Radiology)
Date of Standard: 2011. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) |
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| Devices Affected: |
| Tracheal Tubes Claiming Laser Resistance |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
Complete standard with the following exceptions:
The maximum test duration of 10 seconds specified in Clause 10.10 shall be replaced with a maximum test duration of 30 seconds. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5730 |
Changer, Tube, Endotracheal |
Class 2 |
LNZ |
| §868.5730 |
Tube, Tracheal (W/Wo Connector) |
Class 2 |
BTR |
| §868.5730 |
Tube, Tracheal, Reprocessed |
Class 2 |
NMA |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5740 |
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) |
Class 2 |
CBI |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Robert James |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 1216 |
| Silver Spring MD 20993 |
| 301/796-2487 |
| Email: robert.james@fda.hhs.gov |
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