Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-58: ASTM G175-03 (Reapproved 2011), Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications. (Anesthesias)
Date of Standard: 2003. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
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| (2) | OFFICE OF COMPLIANCE (OC) | | |
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| Devices Affected: |
Oxygen Regulators
Oxygen Conserving devices that incorporate an integral regulator |
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| Processes Affected: |
Design Control Inputs
Premarket notification |
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| Type of Standard: |
| Vertical, National |
| Extent of Recognition: |
| Complete standard and annexes. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.2700 |
Regulator, Pressure, Gas Cylinder |
Class 1 |
CAN |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5905 |
Conserver, Oxygen |
Class 2 |
NFB |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Christy Foreman |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1676 |
| Silver Spring MD 20993 |
| 301/796-6382 |
| Email: christy.foreman@fda.hhs.gov |
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