The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Tympanic Temperature Sensor.
| Device ID | K873205 |
| 510k Number | K873205 |
| Device Name: | TYMPANIC TEMPERATURE SENSOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 3118 ALPINE Santa Ana, CA 92704 |
| Contact | Anthony V Beran |
| Correspondent | Anthony V Beran RESPIRATORY SUPPORT PRODUCTS, INC. 3118 ALPINE Santa Ana, CA 92704 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-14 |
| Decision Date | 1988-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20695085000614 | K873205 | 000 |
| 20695085000607 | K873205 | 000 |
| 20695085000591 | K873205 | 000 |
| 10695085000587 | K873205 | 000 |