The following data is part of a premarket notification filed by Belmont Instrument Corp. with the FDA for The Belmont Buddy Lite Fluid Warmer.
| Device ID | K112639 |
| 510k Number | K112639 |
| Device Name: | THE BELMONT BUDDY LITE 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 | 2011-09-12 |
| Decision Date | 2011-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 70896128002441 | K112639 | 000 |
| 60896128002444 | K112639 | 000 |
| 50896128002447 | K112639 | 000 |
| 40896128002440 | K112639 | 000 |
| 30896128002443 | K112639 | 000 |
| 20896128002446 | K112639 | 000 |
| 10896128002449 | K112639 | 000 |
| 00896128002442 | K112639 | 000 |