The following data is part of a premarket notification filed by Makol Medical Instruments Corp. with the FDA for Clinical Glass Thermometer.
| Device ID | K942483 |
| 510k Number | K942483 |
| Device Name: | CLINICAL GLASS THERMOMETER |
| Classification | Thermometer, Clinical Mercury |
| Applicant | MAKOL MEDICAL INSTRUMENTS CORP. 3313 N.W. 74TH AVE. Miami, FL 33122 |
| Contact | Eduardo J Martinez |
| Correspondent | Eduardo J Martinez MAKOL MEDICAL INSTRUMENTS CORP. 3313 N.W. 74TH AVE. Miami, FL 33122 |
| Product Code | FLK |
| CFR Regulation Number | 880.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-25 |
| Decision Date | 1995-03-28 |