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510(k) K932581

BREATHING BAGS by Med-Plastics Intl., Inc. — Product Code BTC

K932581 is an FDA 510(k) premarket notification submitted by Med-Plastics Intl., Inc. for the device "BREATHING BAGS". The FDA issued a decision of Substantially Equivalent on July 16, 1993. The device falls under product code BTC (Bag, Reservoir), a Class I device regulated under 21 CFR 868.5320. Med-Plastics Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1993
Date Received
May 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Reservoir
Device Class
Class I
Regulation Number
868.5320
Review Panel
AN
Submission Type

Other clearances by Med-Plastics Intl., Inc.

  • K946209 — DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME (June 8, 1995)
  • K942568 — ADULT ANESTHESIA BREATHING CIRCUIT (June 10, 1994)
  • K942567 — MASS SPECTROMETRY MONITORING LINES AND CONNECTORS (June 10, 1994)
  • K942571 — HYPER-INFLATION BAG (June 10, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)
  • K942570 — MAPLESON D CIRCUIT (June 10, 1994)
  • K932577 — PEDIATRIC GAS SAMPLING (July 22, 1993)
  • K932575 — ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (July 22, 1993)
  • K932576 — PEDIATRIC TEMPERATURE MONITORING CIRCUITS (July 22, 1993)

Other clearances for product code BTC

  • K181424 — PeDIA (September 25, 2018)
  • K940220 — REBREATHER BAGS (May 27, 1994)
  • K932496 — PRECISION MED PRODUCTS, LTD. BREATHING BAGS (July 16, 1993)
  • K932584 — BREATHING BAGS (July 16, 1993)
  • K932191 — BREATHING BAGS (July 2, 1993)
  • K894906 — ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER (September 18, 1989)
  • K880680 — KING SYSTEMS, BREATHING BAG (March 3, 1988)
  • K864822 — VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (January 15, 1987)
  • K841412 — ROLLED NECK W/TAP (April 18, 1984)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)

FDA data resources