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510(k) K932496

PRECISION MED PRODUCTS, LTD. BREATHING BAGS by Precision Med Products, Ltd. — Product Code BTC

K932496 is an FDA 510(k) premarket notification submitted by Precision Med Products, Ltd. for the device "PRECISION MED PRODUCTS, LTD. 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. Precision Med Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1993
Date Received
May 25, 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 Precision Med Products, Ltd.

  • K932708 — PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS (July 23, 1993)
  • K932711 — PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS (July 23, 1993)
  • K932706 — PRECISION MED PRODUCTS LTD. VENTILATOR HOSE (July 23, 1993)
  • K932707 — ADULT ANESTHESIA BREATHING CIRCUIT (July 23, 1993)
  • K932709 — PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM (July 23, 1993)
  • K932710 — GAS SAMPLING LINES AND CONNECTORS (July 23, 1993)
  • K932488 — PMP, LTD. PEDIATRIC GAS SAMPLING CIRCUITS (July 22, 1993)
  • K932489 — PMP, LTD. ADULT TEMP. MONITORING ANESTHESIA CIR. (July 22, 1993)
  • K932712 — PRECISION MED PRODUCTS LTD VOLUME VENTILATORS (July 22, 1993)
  • K932497 — PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING (July 22, 1993)

Other clearances for product code BTC

  • K181424 — PeDIA (September 25, 2018)
  • K940220 — REBREATHER BAGS (May 27, 1994)
  • K932581 — 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