The following data is part of a premarket notification filed by Omega Medical Corp. with the FDA for Surface Temperature Scanner.
| Device ID | K873010 |
| 510k Number | K873010 |
| Device Name: | SURFACE TEMPERATURE SCANNER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | OMEGA MEDICAL CORP. 251-A WINDWARD PASSAGE Clearwater, FL 34630 |
| Contact | Looney, Jr |
| Correspondent | Looney, Jr OMEGA MEDICAL CORP. 251-A WINDWARD PASSAGE Clearwater, FL 34630 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-04 |
| Decision Date | 1987-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10834098000522 | K873010 | 000 |
| 10834098000508 | K873010 | 000 |
| 10834098000379 | K873010 | 000 |
| 10834098000355 | K873010 | 000 |