The following data is part of a premarket notification filed by Amg Medical Inc. with the FDA for Amg Med Brand Clinical Glass Thermometer.
| Device ID | K940380 |
| 510k Number | K940380 |
| Device Name: | AMG MED BRAND CLINICAL GLASS THERMOMETER |
| Classification | Thermometer, Clinical Mercury |
| Applicant | AMG MEDICAL INC. 8531 DELMEADE MONTREAL, QUE H4T 1M1 Canada, CA |
| Contact | Andre Renaud |
| Correspondent | Andre Renaud AMG MEDICAL INC. 8531 DELMEADE MONTREAL, QUE H4T 1M1 Canada, CA |
| Product Code | FLK |
| CFR Regulation Number | 880.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-26 |
| Decision Date | 1994-05-04 |