Submission Details
| 510(k) Number | K940380 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 26, 1994 |
| Decision Date | May 04, 1994 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Traditional
AMG MED BRAND CLINICAL GLASS THERMOMETER
May 1994
Decision
98d
Days
Class 2
Risk
About This 510(k) Submission
K940380 is an FDA 510(k) clearance for the AMG MED BRAND CLINICAL GLASS THERMOMETER, a Thermometer, Clinical Mercury (Class II — Special Controls, product code FLK), submitted by Amg Medical, Inc. (Canada, CA). The FDA issued a Cleared decision on May 4, 1994, 98 days after receiving the submission on January 26, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2920.
Device Classification
| Product Code | FLK — Thermometer, Clinical Mercury |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2920 |
Manufacturer
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