Submission Details
| 510(k) Number | K940394 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
K940394 - AMG MED BRAND CLINICAL GLASS THERMOMETER
(FDA 510(k) Clearance)
May 1994
Decision
98d
Days
Class 2
Risk
K940394 is an FDA 510(k) clearance for the AMG MED BRAND CLINICAL GLASS THERMOMETER. This device is classified as a Thermometer, Clinical Mercury (Class II — Special Controls, product code FLK).
Submitted by Technolab Industries (Canada) , Ltd. (Montreal, Quebec, 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 FDA 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 |
Similar Devices — FLK Thermometer, Clinical Mercury
All 32
K960185 · Amsia Intl., Inc.
· Mar 1996
K960224 · Rg Ent., Inc.
· Mar 1996
K953465 · Kentron Health Care, Inc.
· Dec 1995
K942483 · Makol Medical Instruments Corp.
· Mar 1995
K941673 · Polymedica Industries, Inc.
· Aug 1994
K940380 · Amg Medical, Inc.
· May 1994