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510(k) K781216

INFUSION CONTROLLER, PARENTERAL by National Patent Development Corp. — Product Code FLS

K781216 is an FDA 510(k) premarket notification submitted by National Patent Development Corp. for the device "INFUSION CONTROLLER, PARENTERAL". The FDA issued a decision of Substantially Equivalent on August 10, 1978. The device falls under product code FLS (Monitor, Apnea, Facility Use), a Class II device regulated under 21 CFR 868.2377. National Patent Development Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1978
Date Received
July 17, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Apnea, Facility Use
Device Class
Class II
Regulation Number
868.2377
Review Panel
AN
Submission Type

Other clearances by National Patent Development Corp.

  • K843974 — VARIABLE TEMPERATURE CAUTERY DEVICE (February 26, 1985)
  • K832699 — HYDRON WOUND DRESSING FAST SEAT KIT (April 27, 1984)
  • K822793 — PIO ROOT CANAL INDICATOR (October 22, 1982)
  • K820028 — ZEON COMPOSITE RESIN LIGHT CURE SYS (March 11, 1982)
  • K820006 — ZEON COMPOSITE RESIN SYSTEM (January 22, 1982)
  • K811446 — HYDRON WOUND DRESSING KIT (June 12, 1981)
  • K801484 — ROOT CANAL FILLING APPLICATOR NEEDLES (July 21, 1980)
  • K801483 — MARK IV SYRINGE (July 21, 1980)
  • K801482 — HYDRON ROOT CANAL FILLING MATERIAL (July 21, 1980)
  • K792136 — HYPO-ALLERGENIC PLASTIC TAPE (January 16, 1980)

Other clearances for product code FLS

  • K011597 — SMARTMONITOR 2, MODEL 4000 (January 11, 2002)
  • K991087 — HANNAH WIRELESS VITAL SIGNS MONITOR (January 12, 2000)
  • K962865 — REMBRANDT SYSTEM (October 25, 1996)
  • K951246 — PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY O (February 2, 1996)
  • K894973 — RESPITRACE PLUS (October 30, 1989)
  • K832999 — RESPIRATION MONITOR (February 13, 1984)
  • K830778 — MONITORING KIT AMK-1 (October 14, 1983)
  • K822077 — RESPIRATION MONITOR TYPE MR-10 (October 6, 1982)
  • K821721 — CLINICAL DATA APNEA DETECTOR (July 13, 1982)
  • K820943 — SYSTEM I INFANT MONITORING SYS (May 3, 1982)

FDA data resources