The following data is part of a premarket notification filed by Sentry Medical Products, Inc. with the FDA for Accutemp Plus.
| Device ID | K881670 |
| 510k Number | K881670 |
| Device Name: | ACCUTEMP PLUS |
| Classification | Warmer, Infant Radiant |
| Applicant | SENTRY MEDICAL PRODUCTS, INC. 2615 SOUTH ORANGE AVE. Santa Ana, CA 92704 |
| Contact | David Sheraton |
| Correspondent | David Sheraton SENTRY MEDICAL PRODUCTS, INC. 2615 SOUTH ORANGE AVE. Santa Ana, CA 92704 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-18 |
| Decision Date | 1988-11-22 |