FDA.reportPublic FDA data

510(k) K181424

Device
PeDIA
Applicant
PeDIA, LLC
510(k) number
K181424
Product code
BTC  
Decision
Substantially Equivalent (SESE)
Decision date
2018-09-25
Date received
2018-05-31
Regulation
868.5320
Classification name
Bag, Reservoir
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Diane Miller
Address
2804 Albany Ct. Fairfax VA US 22031 22031

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BTC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940220REBREATHER BAGSZefon Medical Products1994-05-27
K932584BREATHING BAGSMerit Medical Systems, Inc.1993-07-16
K932581BREATHING BAGSMed-Plastics Intl., Inc.1993-07-16
K932496PRECISION MED PRODUCTS, LTD. BREATHING BAGSPrecision Med Products, Ltd.1993-07-16
K932191BREATHING BAGSLife Shield Healthcare Products, Inc.1993-07-02
K894906ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITERMed-Tek Corp.1989-09-18
K880680KING SYSTEMS, BREATHING BAGKing Systems Corp.1988-03-03
K864822VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYSSurgidyne, Inc.1987-01-15
K841411ROLLED NECK W/PLUGWarne Surgical Products, Ltd.1984-04-18
K841412ROLLED NECK W/TAPWarne Surgical Products, Ltd.1984-04-18
K830399COUPLING/VALVEKhi, Inc.1983-03-10
K830056ARTEC TWIST VALVEArtec Environmental Monitoring Division1983-03-09
K822216VOLUMETRIC CONTROLLERQuest Medical, Inc.1982-08-16
K822116ANESTHESIA BREATHING BAG, VARIOUS SIZESLife Design Systems, Inc.1982-08-16
K821309ESPREE', BREATHING BAGEsp Plastics, Inc.1982-05-21

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases