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510(k) K810116

ISOROBIC SKINFOLD CALIPER by Fitness Motivation Institute of America — Product Code KTZ

K810116 is an FDA 510(k) premarket notification submitted by Fitness Motivation Institute of America for the device "ISOROBIC SKINFOLD CALIPER". The FDA issued a decision of Substantially Equivalent on February 4, 1981. 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
February 4, 1981
Date Received
January 15, 1981
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

Other clearances for product code KTZ

  • K921266 — NK MEDICAL MICROMETER, MODEL MC001 (July 14, 1992)
  • K841687 — SKYNDEX ELECTRONIC BODY FAT CALCULA (June 28, 1984)
  • K831898 — SCOLIMETER (July 19, 1983)
  • K820659 — A CALIPER (March 19, 1982)
  • K800363 — PARKE-DAVIS TOTAL KNEE PROSTHESIS (March 10, 1980)
  • K760521 — TAPE MEASURE (November 12, 1976)

FDA data resources