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510(k) K940220

REBREATHER BAGS by Zefon Medical Products — Product Code BTC

K940220 is an FDA 510(k) premarket notification submitted by Zefon Medical Products for the device "REBREATHER BAGS". The FDA issued a decision of Substantially Equivalent on May 27, 1994. The device falls under product code BTC (Bag, Reservoir), a Class I device regulated under 21 CFR 868.5320. Zefon Medical Products has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1994
Date Received
January 21, 1994
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 Zefon Medical Products

  • K934462 — ADULT ANESTHESIA BREATHING CIRCUIT KITS (March 1, 1994)
  • K930957 — ZEFON GAS SAMPLING LINES (July 2, 1993)
  • K924889 — ZEFON ADULT ANESTHESIA BREATHING CIRCUIT (March 19, 1993)

Other clearances for product code BTC

  • K181424 — PeDIA (September 25, 2018)
  • K932496 — PRECISION MED PRODUCTS, LTD. BREATHING BAGS (July 16, 1993)
  • 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)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)
  • K841412 — ROLLED NECK W/TAP (April 18, 1984)

FDA data resources