The following data is part of a premarket notification filed by Bnos Meditech, Ltd. with the FDA for Bnos Microvent(tm), Model Ac And Model Ao.
Device ID | K930533 |
510k Number | K930533 |
Device Name: | BNOS MICROVENT(TM), MODEL AC AND MODEL AO |
Classification | Stethoscope, Esophageal, With Electrical Conductors |
Applicant | BNOS MEDITECH, LTD. MILL LANE STEBBING Essex, GB Cm6 3sl |
Contact | Howard Buckenlham |
Correspondent | Howard Buckenlham BNOS MEDITECH, LTD. MILL LANE STEBBING Essex, GB Cm6 3sl |
Product Code | BZT |
CFR Regulation Number | 868.1920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-02 |
Decision Date | 1993-03-29 |