510(k) K100585

MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 by Gaymar Industries, Inc. — Product Code DWJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 20, 2011
Date Received: March 2, 2010
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 Gaymar Industries, Inc.

K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP (May 8, 2008)
K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM (April 30, 1997)
K963067 — SOF. PRESS EPC 51 SYSTEM (January 28, 1997)
K961854 — SPR PLUS II OVERLAY SYSTEM (CL250/CL212 (August 9, 1996)
K942881 — TC 3000 (May 23, 1995)
K930345 — TC2000 POWER UNIT AND ACCESSORIES (August 6, 1993)
K914921 — SCM-3 AND ACCESSORIES (March 12, 1992)
K914805 — TC-1000, TC-1050 SYSTEM (January 7, 1992)
K914851 — CLA-1400 SYSTEM (November 13, 1991)
K912051 — MEDI-THERM (MTA-5900) & DETACHABLE HOSES (July 30, 1991)

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