510(k) K910905
K910905 is an FDA 510(k) premarket notification submitted by Life Sciences Manufacturing, Inc. for the device "SFA-II MICROPROCESSOR-CONTROLLED MODULE". The FDA issued a decision of Substantially Equivalent on July 24, 1991. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Life Sciences Manufacturing, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 1991
- Date Received
- March 5, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier And Signal Conditioner, Transducer Signal
- Device Class
- Class II
- Regulation Number
- 870.2060
- Review Panel
- CV
- Submission Type