510(k) K791730
K791730 is an FDA 510(k) premarket notification submitted by Research Development Corp. for the device "RING-ORIFICE, TURBULENT FLOW PNEUMOT". The FDA issued a decision of Substantially Equivalent on November 16, 1979. The device falls under product code JAX (Pneumotachometer), a Class II device regulated under 21 CFR 868.2550. Research Development Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1979
- Date Received
- August 28, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pneumotachometer
- Device Class
- Class II
- Regulation Number
- 868.2550
- Review Panel
- AN
- Submission Type