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 | K090508 |
| 510k Number | K090508 |
| 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 | 2009-02-26 |
| Decision Date | 2009-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80896128002493 | K090508 | 000 |
| 10896128002494 | K090508 | 000 |
| 10896128002548 | K090508 | 000 |
| 20896128002491 | K090508 | 000 |
| 20896128002545 | K090508 | 000 |
| 30896128002498 | K090508 | 000 |
| 30896128002542 | K090508 | 000 |
| 40896128002495 | K090508 | 000 |
| 50896128002492 | K090508 | 000 |
| 60896128002499 | K090508 | 000 |
| 70896128002496 | K090508 | 000 |
| 00896128002497 | K090508 | 000 |