510(k) K914382

LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM by Progressive Dynamics, Inc. — Product Code DWJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 21, 1992
Date Received: October 1, 1991
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 Progressive Dynamics, Inc.

K952329 — LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM (January 17, 1996)
K944688 — LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR (November 1, 1994)
K933764 — LIFE-AIR 1000 PATIENT WARMING COVER (November 9, 1993)
K933593 — LUMINOUS 150 FIBEROPTIC ILLUMINATOR (October 28, 1993)
K921866 — LUMINOUS 250 FIBEROPTIC ILLUMINATOR (July 8, 1992)
K914383 — LIFE-AIR 1000 PATIENT WARMING COVERS (March 30, 1992)

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