The following data is part of a premarket notification filed by Natus Nicolet Ireland Ltd with the FDA for Natus Warmette Blanket And Dual Cabinets.
| Device ID | K132110 |
| 510k Number | K132110 |
| Device Name: | NATUS WARMETTE BLANKET AND DUAL CABINETS |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | NATUS NICOLET IRELAND LTD IDA BUSINESS PARK Gort, County Galway, IE Ie |
| Contact | Michael Galvin |
| Correspondent | Michael Galvin NATUS NICOLET IRELAND LTD IDA BUSINESS PARK Gort, County Galway, IE Ie |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-09 |
| Decision Date | 2013-10-03 |
| Summary: | summary |