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 |