Home / 510(k) Clearances / K822961

510(k) K822961

PORTA FIB III by Narco Scientific — Product Code LDD

K822961 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "PORTA FIB III". The FDA issued a decision of Substantially Equivalent on November 1, 1982. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Narco Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1982
Date Received
October 5, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type

Other clearances by Narco Scientific

  • K830338 — NARCOTRACE 80 (December 22, 1983)
  • K831429 — AS 191 ECG TELEMETRY MODULE (October 14, 1983)
  • K831428 — AS 1740 INTERFACE MODULE (October 14, 1983)
  • K822835 — PZ-800 VOLUME VENTILATOR (September 29, 1983)
  • K831430 — AIR SHIELDS AS-100 MONIORING SYS-AS105 (September 12, 1983)
  • K831460 — AS 30/TCP MODULE (July 12, 1983)
  • K830123 — DISP. YANKAVER SURG. SUCTION INSTRUMENT (June 8, 1983)
  • K831028 — TI-1000 TRANSPORT INCUBATOR (May 9, 1983)
  • K823899 — INFANT CARE SYSTEM (April 14, 1983)
  • K830680 — AIR-SHIELDS VENTIMETER VENTILATOR-CONTR (April 8, 1983)

Other clearances for product code LDD

  • K203231 — Switched Internal Paddles (January 11, 2021)
  • K200849 — Tempus LS - Manual (July 24, 2020)
  • K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators (June 3, 2019)
  • K150349 — Rapid Hair Removal Pads (July 14, 2015)
  • K140502 — ZOLL E SERIES ALS (November 6, 2014)
  • K103651 — CARDIOMED (October 4, 2011)
  • K103783 — EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDI (June 16, 2011)
  • K103334 — CARDIO MED (January 18, 2011)
  • K103159 — CARDIO MED MODEL A102, H104, O101, P103, AND Z100 (January 11, 2011)
  • K102468 — ZOLL PROPAQ MD (September 30, 2010)

FDA data resources