The following data is part of a premarket notification filed by International Hospital Supply Co. with the FDA for Phoenix Infant Radiant Warmer, Model 100nws.
| Device ID | K033040 |
| 510k Number | K033040 |
| Device Name: | PHOENIX INFANT RADIANT WARMER, MODEL 100NWS |
| Classification | Warmer, Infant Radiant |
| Applicant | INTERNATIONAL HOSPITAL SUPPLY CO. AMSTEL 320-1 Amsterdam, NL 1017ap |
| Contact | Dagmar Maser |
| Correspondent | Dagmar Maser INTERNATIONAL HOSPITAL SUPPLY CO. AMSTEL 320-1 Amsterdam, NL 1017ap |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2003-12-17 |