The following data is part of a premarket notification filed by Belmont Instrument Corp. with the FDA for Belmont Buddy Plus Fluid Warmer.
| Device ID | K062774 |
| 510k Number | K062774 |
| Device Name: | BELMONT BUDDY PLUS FLUID WARMER |
| Classification | Warmer, Blood, Non-electromagnetic Radiation |
| Applicant | BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica, MA 01821 |
| Contact | Uraiwan P Labadini |
| Correspondent | Uraiwan P Labadini BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica, MA 01821 |
| Product Code | BSB |
| CFR Regulation Number | 864.9205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-18 |
| Decision Date | 2006-10-19 |
| Summary: | summary |