Thermal Probe Cover
FDA 510(k) K915831 · Vermont Medical, Inc.
510(k) numberK915831
Submission
- Device name
- Thermal Probe Cover
- Applicant
- Vermont Medical, Inc.
Bellows Falls, VT, US - Received
- December 30, 1991
- Decision date
- June 8, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMT – Warmer, Infant Radiant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5130
- Specialty
- General Hospital
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| K122267 | Giraffe and Panda WarmersFMT · Special | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 10/02/2012SE |
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| K021537 | Multipurpose Neuroplus Electrode, Model A10005GXY · Traditional | 03/03/2003SE |
| K010638 | Neuroplus, Model A10040, A10041, A10042, A10043GXY · Traditional | 05/03/2001SE |
| K921498 | Ver Med A10011 PNS Dual Element ElectrodeBXM · Traditional | 06/09/1993SE |
| K911687 | Ver-Med A10020 Resting EKG ElectrodeDRX · Traditional | 10/10/1991SE |
| K910139 | Ver-Med A10014 Resting EKG Electrode & A10021DRX · Traditional | 08/15/1991SE |
| K905489 | Ver-Med A10017 Universal ElectrodeDRX · Traditional | 03/21/1991SE |
| K781430 | Pregelled Disposable E.K.G. ElectrodeDRX · Traditional | 10/31/1978SE |
Questions and answers
When was Thermal Probe Cover cleared by the FDA?
Thermal Probe Cover (K915831) received a 510(k) decision of Substantially Equivalent on June 8, 1992, 161 days after the submission was received.
What is the product code of K915831?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.