FDA 510(k) Applications for Medical Device Product Code "BTC"
(Bag, Reservoir)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K830056 |
ARTEC ENVIRONMENTAL MONITORING DIVISION |
ARTEC TWIST VALVE |
03/09/1983 |
K791463 |
CAMERON MEDICAL CORP. |
"PARA-VENT" |
09/17/1979 |
K800155 |
DRYDEN CORP. |
DISPOSAL LITER BREATHING BAG |
02/21/1980 |
K821309 |
ESP PLASTICS, INC. |
ESPREE', BREATHING BAG |
05/21/1982 |
K830399 |
KHI, INC. |
COUPLING/VALVE |
03/10/1983 |
K880680 |
KING SYSTEMS CORP. |
KING SYSTEMS, BREATHING BAG |
03/03/1988 |
K822116 |
LIFE DESIGN SYSTEMS, INC. |
ANESTHESIA BREATHING BAG, VARIOUS SIZES |
08/16/1982 |
K932191 |
LIFE SHIELD HEALTHCARE PRODUCTS, INC. |
BREATHING BAGS |
07/02/1993 |
K932581 |
MED-PLASTICS INTL., INC. |
BREATHING BAGS |
07/16/1993 |
K894906 |
MED-TEK CORP. |
ANESTHESIA BREATHING BAGS "SIZES 1/2, 1,2,3 LITER" |
09/18/1989 |
K791910 |
MEM MEDICAL, INC. |
THREE LITER BAG #M-512 |
10/09/1979 |
K932584 |
MERIT MEDICAL SYSTEMS, INC. |
BREATHING BAGS |
07/16/1993 |
K181424 |
PeDIA, LLC |
PeDIA |
09/25/2018 |
K932496 |
PRECISION MED PRODUCTS, LTD. |
PRECISION MED PRODUCTS, LTD. BREATHING BAGS |
07/16/1993 |
K822216 |
QUEST MEDICAL, INC. |
VOLUMETRIC CONTROLLER |
08/16/1982 |
K864822 |
SURGIDYNE, INC. |
VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS |
01/15/1987 |
K841411 |
WARNE SURGICAL PRODUCTS, LTD. |
ROLLED NECK W/PLUG |
04/18/1984 |
K841412 |
WARNE SURGICAL PRODUCTS, LTD. |
ROLLED NECK W/TAP |
04/18/1984 |
K940220 |
ZEFON MEDICAL PRODUCTS |
REBREATHER BAGS |
05/27/1994 |
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