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510(k) K832356

PORTABLE OPERAT. RM. MONITORS HS30/40 by Medtel Pty. , Ltd. — Product Code BZN

K832356 is an FDA 510(k) premarket notification submitted by Medtel Pty. , Ltd. for the device "PORTABLE OPERAT. RM. MONITORS HS30/40". The FDA issued a decision of Substantially Equivalent on October 28, 1983. The device falls under product code BZN (Cart, Emergency, Cardiopulmonary (Excluding Equipment)), a Class I device regulated under 21 CFR 868.6175. Medtel Pty. , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1983
Date Received
July 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Device Class
Class I
Regulation Number
868.6175
Review Panel
AN
Submission Type

Other clearances by Medtel Pty. , Ltd.

  • K820670 — HS17/HS18 SERIES MONITORS (April 9, 1982)
  • K820671 — CM10 CENTRAL MONITORING SYSTEM (April 1, 1982)
  • K820399 — HS20 PORT. OPERATING ROOM MONITOR (March 22, 1982)
  • K802184 — HS10 PORTABLE OPERATING ROOM MONITOR (September 26, 1980)
  • K800243 — D668 & D664 CENTRAL MONITORING SYSTEMS (April 10, 1980)
  • K791839 — H59 CRITICAL CARE MONITOR (October 1, 1979)
  • K791838 — HSH/H512 ADULT PHYSIOLOGICAL MONITORS (October 1, 1979)

Other clearances for product code BZN

  • K924373 — ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP (November 25, 1992)
  • K872558 — CART, EMERGENCY, CARDIOPULMONARY (July 24, 1987)
  • K850761 — MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C (September 19, 1985)
  • K840264 — SERVO CART 170 (February 4, 1984)
  • K832697 — RMP INTUBATION EQUIP. STORAGE TRAY (December 27, 1983)
  • K832355 — CRASH CART (October 28, 1983)
  • K772320 — EMERGENCY CART (January 3, 1978)

FDA data resources