Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-87: IEC 60601-2-23 Edition 3.0 2011-02, Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment. (Anesthesia)
Date of Standard: 2011. |
| Address of Standards Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
|
SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | | | |
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| Devices Affected: |
| Transcutaneous oxygen and carbon dioxide partial pressure monitors |
|
| Processes Affected: |
| 510(k), PMA, ID,E PDP, HDE, Design Control Input |
|
| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
| Complete Standard and its annexes. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.2480 |
Monitor, Carbon-Dioxide, Cutaneous |
Class 2 |
LKD |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.2500 |
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
Class 2 |
KLK |
| §868.2500 |
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia |
Class 2 |
LPP |
| |
|
| Relevant Guidance: |
| Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA |
|
| FDA Technical Contact: |
| Neel Patel |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2532 |
| Silver Spring MD 20993 |
| 301/796-6274 |
| Email: neel.patel@fda.hhs.gov |
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