510(k) K930345

TC2000 POWER UNIT AND ACCESSORIES by Gaymar Industries, Inc. — Product Code DWJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 6, 1993
Date Received: January 25, 1993
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.

K100585 — MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 (January 20, 2011)
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)
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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K242964 — Celsi Warmer (June 20, 2025)
K243942 — Arctic Sun Stat Temperature Management System (April 30, 2025)
K232627 — HotDog Warming Mattress + Return Electrode (April 18, 2024)
K232502 — Cocoon Convective Warming System, Model CWS7000 (February 21, 2024)
K231211 — Medline ComfortTemp Patient Warming System (December 1, 2023)
K232638 — FilteredFlo Warming Blankets (October 24, 2023)
K232844 — The IQoolTM System (October 4, 2023)
K232508 — Barrier EasyWarm Active Self-Warming Blanket (September 15, 2023)
K231596 — IOB Temperature Management System (June 30, 2023)