The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for 1.1, 1.2, 1.3 Temperature Probes.
| Device ID | K912650 |
| 510k Number | K912650 |
| Device Name: | 1.1, 1.2, 1.3 TEMPERATURE PROBES |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Alberto Velez |
| Correspondent | Alberto Velez VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-17 |
| Decision Date | 1991-08-16 |