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510(k) K900419

CRYOTRON-UL30 by Henley Intl. — Product Code IMF

K900419 is an FDA 510(k) premarket notification submitted by Henley Intl. for the device "CRYOTRON-UL30". The FDA issued a decision of Substantially Equivalent on February 27, 1990. The device falls under product code IMF (Unit, Chilling), a Class I device regulated under 21 CFR 890.5940. Henley Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1990
Date Received
January 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Chilling
Device Class
Class I
Regulation Number
890.5940
Review Panel
PM
Submission Type

Other clearances by Henley Intl.

  • K943449 — NEUROLOGICAL DIAGNOSTIC DEVICES (November 15, 1995)
  • K926279 — UPPER BODY EXERCISER (May 5, 1994)
  • K926278 — STAIR CLIMBER (May 5, 1994)
  • K926287 — EXERCISE BICYCLE (March 22, 1994)
  • K926314 — HYDRA FITNESS MODEL 311 TOTAL POWER (March 18, 1994)
  • K926313 — COMPUTERIZED TESTING AND EXERCISE SYSTEMS (February 4, 1994)
  • K915864 — MONOTRODE CUTANEOUS ELECTRODE (July 21, 1993)
  • K922036 — SONOPULS 591 (June 29, 1993)
  • K926316 — TRUE-TRAC, STRATUS (March 24, 1993)
  • K920983 — SONOPULS 590 (March 9, 1993)

Other clearances for product code IMF

  • K871112 — PELTIERTHERAPY(C) HEAT/COLD TREATMENT (May 6, 1987)

FDA data resources