EvaQMax Smoke Evacuation System
Bio Protech, Inc.
BIO PROTECH, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9710582 | 3003514332 | BIO PROTECH, INC. | 1 | N | 2026-01-01 | 151-3, Donghwagongdan-ro Munmak-eup Wonju-si Gangwon KR 26365 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 20372 | 1946204251 | K192035 | EvaQMax Smoke Evacuation System | FYD | 2019-08-29 |
| 20372 | 1411977017 | K153019 | Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes | GXY | 2016-03-21 |
| 20372 | 1566551344 | K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes | IKT | 2016-06-03 |
| 20372 | 1164587280 | K143103 | PROPENCIL Smoke Pencil | GEI | 2015-07-16 |
| 20372 | 1405272912 | K142099 | CUTANEOUS ELECTRODES | GXY | 2014-11-17 |
| 20372 | 1970780211 | K111270 | REUSABLE STIMULATING ELECTRODES | GXY | 2011-09-13 |
| 20372 | 1011095965 | K100246 | MAX-IF1000 | LIH | 2010-11-24 |
| 20372 | 1080017306 | K092761 | PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C | GEI | 2009-11-24 |
| 20372 | 1972035945 | K092732 | PROPENCIL ESU PENCIL | GEI | 2009-11-25 |
| 20372 | 1463017031 | K091248 | MAXEMS, MODELS 1000 AND 2000 | IPF | 2009-11-30 |
| 20372 | 1920956911 | K083494 | ULTIMA FIVE | GZJ | 2009-01-06 |
| 20372 | 1059444266 | K083148 | TELECTRODE WET GEL ECG ELECTRODE | DRX | 2008-11-07 |
| 20372 | 2043442874 | K073438 | PROSTIM 1000/2000 | GZJ | 2008-02-07 |
| 20372 | 1164406684 | K073360 | PROPLATE | GEI | 2007-12-19 |
| 20372 | 1635032963 | K053011 | PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 | DRX | 2005-12-14 |
| 20372 | 1031991674 | K042301 | PROTENS ELECTRODE | GXY | 2004-09-03 |
| 20372 | 2038139356 | K040784 | PROTAB ECG TABB ELECTRODE | DRX | 2004-04-07 |
| 20372 | 1060557661 | K030375 | SOFT-TOUCH TENS ELECTRODE | GXY | 2003-05-05 |
| 20372 | 1896382484 | K020003 | ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE | DRX | 2002-11-07 |
| 20372 | 1233608380 | ||||
| 20372 | 1973028628 | ||||
| 20372 | 1251810964 |
Product Codes Associated With Registrations#
PMN#
Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Disposable EP Needle Electrodes, Disposable Hypodermic Needle Electrodes
BIO PROTECH, INC.
Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
BIO PROTECH, INC.
PROPENCIL Smoke Pencil
BIO PROTECH, INC.
CUTANEOUS ELECTRODES
BIO PROTECH, INC.
REUSABLE STIMULATING ELECTRODES
BIO PROTECH, INC.
MAX-IF1000
BIO PROTECH, INC.
MAXEMS, MODELS 1000 AND 2000
BIO PROTECH, INC.
PROPENCIL ESU PENCIL
BIO PROTECH, INC.
PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C
BIO PROTECH, INC.
TELECTRODE WET GEL ECG ELECTRODE
BIO PROTECH, INC.
PROSTIM 1000/2000
BIO PROTECH, INC.
PROPLATE
BIO PROTECH, INC.
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
BIO PROTECH, INC.
PROTENS ELECTRODE
BIO PROTECH, INC.
PROTAB ECG TABB ELECTRODE
BIO PROTECH, INC.
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
BIO PROTECH, INC.