510(k) K781523
K781523 is an FDA 510(k) premarket notification submitted by Gardner Cryogenics for the device "PFT GASES". The FDA issued a decision of Substantially Equivalent on December 1, 1978. The device falls under product code BXY (Flowmeter, Calibration, Gas), a Class I device regulated under 21 CFR 868.2350. Gardner Cryogenics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 1978
- Date Received
- September 5, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flowmeter, Calibration, Gas
- Device Class
- Class I
- Regulation Number
- 868.2350
- Review Panel
- AN
- Submission Type