The following data is part of a premarket notification filed by Belmont Instrument Corp. with the FDA for Microheater.
| Device ID | K031478 |
| 510k Number | K031478 |
| Device Name: | MICROHEATER |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-12 |
| Decision Date | 2003-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00089612002503 | K031478 | 000 |
| 00896128002114 | K031478 | 000 |
| 00896128002510 | K031478 | 000 |
| 00896128002640 | K031478 | 000 |
| 00896128002657 | K031478 | 000 |
| 10896128002098 | K031478 | 000 |
| 10896128002104 | K031478 | 000 |
| 10896128002111 | K031478 | 000 |
| 10896128002500 | K031478 | 000 |
| 00896128002091 | K031478 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MICROHEATER 74155666 not registered Dead/Abandoned |
Interflo Medical, Inc. 1991-04-09 |