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510(k) K960511

GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET by Gibeck, Inc. — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1997
Date Received
February 5, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Thermal Regulating
Device Class
Class II
Regulation Number
870.5900
Review Panel
CV
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Gibeck, Inc.

  • K965016 — ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) (December 2, 1997)
  • K964377 — THERMAL REGULATION SYSTEM BLANKET (April 23, 1997)
  • K964382 — HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(1940 (April 15, 1997)
  • K954828 — ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT (May 2, 1996)
  • K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (August 25, 1995)
  • K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (August 25, 1995)
  • K952845 — HUMID-VENT TRACH-VENT (July 25, 1995)
  • K952844 — HUMID-VENT 2 (July 20, 1995)
  • K952750 — HUMID-VENT 1 (July 20, 1995)
  • K952084 — HUMID-VENT FILTER PEDI (June 12, 1995)

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  • K231211 — Medline ComfortTemp Patient Warming System (December 1, 2023)
  • K232638 — FilteredFlo Warming Blankets (October 24, 2023)
  • K232844 — The IQoolTM System (October 4, 2023)
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