510(k) K802961
K802961 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "TRANSDUCER DOME, CAT.#SD-101". The FDA issued a decision of Substantially Equivalent on December 31, 1980. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Sorensen Research has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1980
- Date Received
- November 21, 1980
- 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