510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Bio Protech, Inc.

Wonju-si Gangwon, KR

BIO PROTECH, INC. appears in FDA device records in Wonju-si Gangwon, KR. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
17
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 17 510(k) clearances for Bio Protech, Inc. between 2002 and 2019. The busiest year on record is 2009, with 3. The most recent is 2019, with 1.

Clearances by year, as a table
510(k) clearance decisions for Bio Protech, Inc., by decision year
YearClearances
20021
20042
20051
20071
20082
20093
20101
20111
20141
20151
20162
20191
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K192035EvaQMax Smoke Evacuation SystemFYDSubstantially Equivalent
K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesIKTSubstantially Equivalent
K153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesGXYSubstantially Equivalent
K143103PROPENCIL Smoke PencilGEISubstantially Equivalent
K142099CUTANEOUS ELECTRODESGXYSubstantially Equivalent
K111270REUSABLE STIMULATING ELECTRODESGXYSubstantially Equivalent
K100246MAX-IF1000LIHSubstantially Equivalent
K091248MAXEMS, MODELS 1000 AND 2000IPFSubstantially Equivalent
K092732PROPENCIL ESU PENCILGEISubstantially Equivalent
K092761PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642CGEISubstantially Equivalent
K083148TELECTRODE WET GEL ECG ELECTRODEDRXSubstantially Equivalent
K073438PROSTIM 1000/2000GZJSubstantially Equivalent
K073360PROPLATEGEISubstantially Equivalent
K053011PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20DRXSubstantially Equivalent
K042301PROTENS ELECTRODEGXYSubstantially Equivalent
K040784PROTAB ECG TABB ELECTRODEDRXSubstantially Equivalent
K020003ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILEDRXSubstantially Equivalent

Registered establishments

FDA registered establishments for Bio Protech, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
97105823003514332BIO PROTECH, INC.151-3, Donghwagongdan-ro, Wonju-si Gangwon 26365 KR2026and 2 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain