The following data is part of a premarket notification filed by K-1 Medical Products, Inc. with the FDA for K-1 Infant Transport System.
| Device ID | K895550 |
| 510k Number | K895550 |
| Device Name: | K-1 INFANT TRANSPORT SYSTEM |
| Classification | Incubator, Neonatal |
| Applicant | K-1 MEDICAL PRODUCTS, INC. 1848 COMMERCIAL ST. San Diego, CA 92113 |
| Contact | David M Price |
| Correspondent | David M Price K-1 MEDICAL PRODUCTS, INC. 1848 COMMERCIAL ST. San Diego, CA 92113 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-13 |
| Decision Date | 1989-12-07 |