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510(k) K792182

ICE CONTAINER I.C.E. by Delta Medical Industries — Product Code IME

K792182 is an FDA 510(k) premarket notification submitted by Delta Medical Industries for the device "ICE CONTAINER I.C.E.". The FDA issued a decision of Substantially Equivalent on November 15, 1979. The device falls under product code IME (Pack, Hot Or Cold, Reusable), a Class I device regulated under 21 CFR 890.5700. Delta Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1979
Date Received
October 29, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Reusable
Device Class
Class I
Regulation Number
890.5700
Review Panel
PM
Submission Type

Other clearances by Delta Medical Industries

  • K833884 — ISOTEC DISPOS. PRESSURE TRANSDUCER (April 17, 1984)
  • K840253 — ONE-WAY AIR VALVE (April 5, 1984)
  • K832470 — INFUSION PUMP (February 28, 1984)
  • K830389 — ACCU-RYNGE PUMP SP-250 (September 12, 1983)
  • K831750 — PM-3 (July 26, 1983)
  • K822761 — DELIVERY TUBE SET #2226 (September 30, 1982)
  • K820912 — PMS-2 PRESSURE MONITOR SEPARATOR (May 18, 1982)
  • K820482 — ACCU-RYNGE INSULIN PUMP #SP-250 (March 26, 1982)
  • K810068 — PEDIATRIC ARTERIAL BLOOD FILTER (January 22, 1981)
  • K802755 — ARTERIAL BLOOD FILTER BF-37 (January 7, 1981)

Other clearances for product code IME

  • K923627 — COLD PACK (April 14, 1993)
  • K915876 — HOTPAD (February 12, 1993)
  • K921446 — HOT OR COLD PACK (THERMIPAQ) (July 13, 1992)
  • K905207 — MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS (January 22, 1991)
  • K882413 — SUBOCCIPITAL ICE PILLOW (November 30, 1988)
  • K863654 — RE-HEATER, HOT PACK (October 23, 1986)
  • K832193 — NICE PACK (August 31, 1983)
  • K831899 — ENSWELL (July 7, 1983)
  • K830981 — MICROPAK MOIST HEAT PAD (June 3, 1983)
  • K830416 — ICY COLD ICE CAP (March 10, 1983)

FDA data resources