The following data is part of a premarket notification filed by Omega Medical Corp. with the FDA for Tympanic Temperature Scanner.
| Device ID | K882949 |
| 510k Number | K882949 |
| Device Name: | TYMPANIC TEMPERATURE SCANNER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | OMEGA MEDICAL CORP. 1221 TURNER ST. # 206 Clearwater, FL 34616 |
| Contact | Looney, Jr |
| Correspondent | Looney, Jr OMEGA MEDICAL CORP. 1221 TURNER ST. # 206 Clearwater, FL 34616 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-14 |
| Decision Date | 1988-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10834098000416 | K882949 | 000 |
| 10834098000430 | K882949 | 000 |
| 10834098000423 | K882949 | 000 |
| 10834098000409 | K882949 | 000 |
| 10834098000393 | K882949 | 000 |
| 10834098000386 | K882949 | 000 |