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 |