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510(k) K790302

PRESSURE MONITOR, MODEL 212 by Zatek — Product Code HRW

K790302 is an FDA 510(k) premarket notification submitted by Zatek for the device "PRESSURE MONITOR, MODEL 212". The FDA issued a decision of Substantially Equivalent on March 21, 1979. The device falls under product code HRW (Dynamometer, Nonpowered), a Class I device regulated under 21 CFR 888.1250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1979
Date Received
February 13, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dynamometer, Nonpowered
Device Class
Class I
Regulation Number
888.1250
Review Panel
NE
Submission Type

Other clearances for product code HRW

  • K971407 — JTECH COMMANDER AND ALGOMETER (April 20, 1998)
  • K970870 — DIGIT-GRIP WITH LCD (DGR002) (May 2, 1997)
  • K894557 — LIGHTSCOPE SET (August 7, 1989)
  • K861396 — HANDHELD DYNAMOMETER, MODEL #160 AND #111 (May 2, 1986)
  • K821631 — PINCH GAUGE, 0-301 LBS. (June 11, 1982)
  • K812343 — PINCH METER (September 11, 1981)
  • K801719 — BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG (August 4, 1980)
  • K791021 — MUSCLE TESTING GUN (June 15, 1979)
  • K772413 — PINCH GUAGE (January 5, 1978)
  • K772415 — DYNAMETER 50 LB. (January 5, 1978)

FDA data resources