510(k) K760520
K760520 is an FDA 510(k) premarket notification submitted by Mcgaw Laboratories for the device "CALIPERS, MCGAW SKINFOLD". The FDA issued a decision of Substantially Equivalent on November 12, 1976. The device falls under product code BXW (Calibrator, Volume, Gas), a Class I device regulated under 21 CFR 868.1870. Mcgaw Laboratories has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1976
- Date Received
- August 26, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Volume, Gas
- Device Class
- Class I
- Regulation Number
- 868.1870
- Review Panel
- AN
- Submission Type