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 W/ Integral Air Compre.
| Device ID | K924324 |
| 510k Number | K924324 |
| Device Name: | K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE |
| Classification | Incubator, Neonatal |
| Applicant | K-1 MEDICAL PRODUCTS, INC. 9932 PROSPECT AVE. SUITE 138 Sant Ee, CA 92071 |
| Contact | Robert J Kopotic |
| Correspondent | Robert J Kopotic K-1 MEDICAL PRODUCTS, INC. 9932 PROSPECT AVE. SUITE 138 Sant Ee, CA 92071 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-27 |
| Decision Date | 1993-11-12 |