The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Vital Signs Dual Display Temperature Monitor, Model 1600.
| Device ID | K934482 |
| 510k Number | K934482 |
| Device Name: | VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Jing Zhang |
| Correspondent | Jing Zhang 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 | 1993-09-14 |
| Decision Date | 1994-05-02 |