510(k) K841687
K841687 is an FDA 510(k) premarket notification submitted by Caldwell, Justiss & Co., Inc. for the device "SKYNDEX ELECTRONIC BODY FAT CALCULA". The FDA issued a decision of Substantially Equivalent on June 28, 1984. The device falls under product code KTZ (Caliper), a Class I device regulated under 21 CFR 888.4150.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1984
- Date Received
- April 23, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Caliper
- Device Class
- Class I
- Regulation Number
- 888.4150
- Review Panel
- OR
- Submission Type