The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Delivery Room Warmer.
| Device ID | K861781 |
| 510k Number | K861781 |
| Device Name: | DELIVERY ROOM WARMER |
| Classification | Warmer, Infant Radiant |
| Applicant | AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Contact | Francis X Casey |
| Correspondent | Francis X Casey AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-08 |
| Decision Date | 1986-07-15 |