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 |