Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-69: ASTM F1464-93 (Reapproved 2005), Standard Specification for Oxygen Concentrators for Domiciliary Use. (Anesthesias)
Date of Standard: 1993. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Oxygen concentrators excluding those intended to supply gas to several patients via a piped medical gas installation or those intended for use in the presence of flammable anesthetic or cleaning agents or both. |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
Complete standard with the following exceptions:
Clause 36 is not recognized, refer to the Draft Reviewer Guidance for Premarket Notifications, November 1993 for electromagnetic compatibility information.
Clause 42.1 is not recognized, refer to the Draft Reviewer Guidance for Premarket Notifications, November 1993 for temperature limits. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5440 |
Generator, Oxygen, Portable |
Class 2 |
CAW |
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| Relevant Guidance: |
| Reviewer Guidance for Premarket Notifications (Draft), November 1993 |
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| FDA Technical Contact: |
| Amy Levelle |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2547 |
| Silver Spring MD 20993 |
| 301/796-6963 |
| Email: amy.levelle@fda.hhs.gov |
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