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510(k) K792592

AMBU UNIVERSAL SUCTION PUMP by Narco Air-Shields — Product Code JCX

K792592 is an FDA 510(k) premarket notification submitted by Narco Air-Shields for the device "AMBU UNIVERSAL SUCTION PUMP". The FDA issued a decision of Substantially Equivalent on January 11, 1980. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Narco Air-Shields has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1980
Date Received
December 17, 1979
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 Narco Air-Shields

  • K820114 — SYSTEM V.HEART RATE/RESPIR. RATE MONIT. (February 12, 1982)
  • K810953 — MODEL 533 PHOTOTHERAPY UNIT (April 23, 1981)
  • K810474 — PROBE COVER (March 31, 1981)
  • K802800 — NARCO AIR-SHEILDS SYS. 100 MONITOR SYS (November 24, 1980)
  • K802126 — ISOLETTE INCUBATOR C-100 (September 26, 1980)
  • K792499 — AMBU PAEDI ANAESTHESIA SYSTEM (December 19, 1979)
  • K792117 — AIR-SHIELDS HEART RATE MONITOR (November 13, 1979)
  • K792118 — AIR-SHIELDS RESUSCITATORS (November 13, 1979)
  • K790552 — AS7 & AS8 MONITORS (May 1, 1979)
  • K790551 — TRANSPORT INCUBATOR (April 24, 1979)

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