510(k) K791294
K791294 is an FDA 510(k) premarket notification submitted by Equilibrated Bio Systems, Inc. for the device "SPIROCAL". The FDA issued a decision of Substantially Equivalent on August 16, 1979. The device falls under product code BXX (Calibrator, Pressure, Gas), a Class I device regulated under 21 CFR 868.2620. Equilibrated Bio Systems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1979
- Date Received
- July 10, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Pressure, Gas
- Device Class
- Class I
- Regulation Number
- 868.2620
- Review Panel
- AN
- Submission Type