The following data is part of a premarket notification filed by Life Sciences Manufacturing, Inc. with the FDA for Sfa-ii Microprocessor-controlled Module.
Device ID | K910905 |
510k Number | K910905 |
Device Name: | SFA-II MICROPROCESSOR-CONTROLLED MODULE |
Classification | Amplifier And Signal Conditioner, Transducer Signal |
Applicant | LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon, NH 03784 |
Contact | Frank E Barber |
Correspondent | Frank E Barber LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon, NH 03784 |
Product Code | DRQ |
CFR Regulation Number | 870.2060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-05 |
Decision Date | 1991-07-24 |