The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Type Interface 9271/1 Incubator/warmer.
| Device ID | K912000 |
| 510k Number | K912000 |
| Device Name: | TYPE INTERFACE 9271/1 INCUBATOR/WARMER |
| Classification | Incubator, Neonatal |
| Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Contact | Lisbeth Isbrandt |
| Correspondent | Lisbeth Isbrandt S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-24 |
| Decision Date | 1992-09-21 |