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FDA 510(k)

MODEL EP-2 CLINICAL STIMULATOR

K-Number: K933069 · 1993-10-21

ApplicantEp Medical, Inc.
Decision Date1993-10-21
Product CodeDTA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL EP-2 CLINICAL STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ep Medical, Inc.. It received FDA 510(k) clearance on 1993-10-21 under 510(k) number K933069. The device is classified under product code DTA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL EP-2 CLINICAL STIMULATOR?

MODEL EP-2 CLINICAL STIMULATOR is a medical device that received FDA 510(k) clearance on 1993-10-21. The listed applicant is Ep Medical, Inc.. The 510(k) number is K933069.

When did MODEL EP-2 CLINICAL STIMULATOR receive FDA 510(k) clearance?

MODEL EP-2 CLINICAL STIMULATOR received FDA 510(k) clearance on 1993-10-21, under 510(k) number K933069.

Who is the listed applicant for MODEL EP-2 CLINICAL STIMULATOR?

The FDA 510(k) record lists Ep Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL EP-2 CLINICAL STIMULATOR?

The FDA product code for MODEL EP-2 CLINICAL STIMULATOR is DTA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Ep Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K935590EP MEDICAL, INC. EP-3 CLINICAL STIMULATORK901320ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG

Related Devices (Code: DTA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163008CareLink SmartSync Device Manager - Pacing System AnalyzerMedtronic, Inc.K101982MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180St Jude Medical, CrmdK073230MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERSBiotronik, Inc.K050884ADAPTER CABLERemington Medical, Inc.K033613MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZERBiotronik, Inc.K022360ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.Biotronik, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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