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510(k) K080005

SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 by Ding Hwa Co., Ltd. — Product Code JCX

K080005 is an FDA 510(k) premarket notification submitted by Ding Hwa Co., Ltd. for the device "SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701". The FDA issued a decision of Substantially Equivalent on April 24, 2008. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Ding Hwa Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2008
Date Received
January 2, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Ding Hwa Co., Ltd.

  • K181398 — DV-300 Aspirator (July 23, 2018)
  • K140809 — CLIQ DV-300 ASPIRATOR (June 23, 2014)
  • K140031 — SUCTION PUMP (April 28, 2014)
  • K132308 — CLIQ DV-300 ASPIRATOR (December 30, 2013)

Other clearances for product code JCX

  • K250964 — Protable Phlegm Suction Unit (JMA D01) (May 11, 2026)
  • K243638 — MV Flow Aspiration Pump (MVFLOWPMP01) (June 13, 2025)
  • K251111 — Cary (May 7, 2025)
  • K243418 — Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing (December 2, 2024)
  • K233428 — Easycess Aspiration Pump (November 3, 2023)
  • K222552 — 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specime (December 9, 2022)
  • K182950 — Acare Suction Unit (August 23, 2019)
  • K190789 — IntelliCartTM System (April 24, 2019)
  • K190105 — ZOOM Aspiration Pump (February 21, 2019)
  • K180115 — TWBM Pump (July 24, 2018)

FDA data resources