The following data is part of a premarket notification filed by Arbo Medical, Inc. with the FDA for Disposable Temperature Probe Cover.
| Device ID | K942905 |
| 510k Number | K942905 |
| Device Name: | DISPOSABLE TEMPERATURE PROBE COVER |
| Classification | Warmer, Infant Radiant |
| Applicant | ARBO MEDICAL, INC. 300 LONG BEACH BLVD. Stratford, CT 06497 |
| Contact | Mark M Petrahai |
| Correspondent | Mark M Petrahai ARBO MEDICAL, INC. 300 LONG BEACH BLVD. Stratford, CT 06497 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-21 |
| Decision Date | 1995-02-27 |