The following data is part of a premarket notification filed by Vermont Medical, Inc. with the FDA for Thermal Probe Cover.
| Device ID | K915831 |
| 510k Number | K915831 |
| Device Name: | THERMAL PROBE COVER |
| Classification | Warmer, Infant Radiant |
| Applicant | VERMONT MEDICAL, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Contact | Pamela Sopczyk |
| Correspondent | Pamela Sopczyk VERMONT MEDICAL, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-30 |
| Decision Date | 1992-06-08 |