Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-66: ISO 9919:2005:, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. (Anesthesias)
Date of Standard: 2005. |
| 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: |
| Pulse oximeters, ear oximeters, reprocessed oximeters, NOT tissue oximeters. |
|
| 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 and any annexes. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.2700 |
Oximeter |
Class 2 |
DQA |
| §870.2700 |
Oximeter, Reprocessed |
Class 2 |
NLF |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.2710 |
Oximeter, Ear |
Class 2 |
DPZ |
| |
|
| Relevant Guidance: |
| Draft Guidance for Industry and FDA Staff - Pulse Oximeters - Premarket Notification Submissions [510(k)s] July 19, 2007 |
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| FDA Technical Contact: |
| Sandy Weininger |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 4212 |
| Silver Spring MD 20993 |
| 301/796-2582 |
| Email: sandy.weininger@fda.hhs.gov |
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