Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-177: ASTM E1112-00 (Reapproved 2011), Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature. (General Plastic Surgery/General Hospital)
Date of Standard: 2006. |
| 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: |
| Clinical Electronic thermometers including contact tympanic thermometers but exclude Infra red thermometers |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.2910 |
Thermometer, Electronic, Clinical |
Class 2 |
FLL |
| |
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| Relevant Guidance: |
| Guidance on the Content of Premarket Notification [510(k)] Submissions for Clinical Electronic Theromometers, Issued March 1993 |
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| FDA Technical Contact: |
| William Burdick |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2522 |
| Silver Spring MD 20993 |
| 301/796-6286 |
| Email: william.burdick@fda.hhs.gov |
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