The following data is part of a premarket notification filed by Coltemp, Inc. with the FDA for Guardian And Andino Models.
| Device ID | K932991 |
| 510k Number | K932991 |
| Device Name: | GUARDIAN AND ANDINO MODELS |
| Classification | Thermometer, Clinical Mercury |
| Applicant | COLTEMP, INC. 8900 SW 107 AVE. STE. 311 Miami, FL 33176 |
| Contact | Manuel Medina |
| Correspondent | Manuel Medina COLTEMP, INC. 8900 SW 107 AVE. STE. 311 Miami, FL 33176 |
| Product Code | FLK |
| CFR Regulation Number | 880.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-18 |
| Decision Date | 1994-01-28 |