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FDA 510(k)

MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000

K-Number: K030332 · 2003-06-06

ApplicantBionicare Medical Technologies, Inc.
Decision Date2003-06-06
Product CodeNYN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Bionicare Medical Technologies, Inc.. It received FDA 510(k) clearance on 2003-06-06 under 510(k) number K030332. The device is classified under product code NYN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000?

MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 is a medical device that received FDA 510(k) clearance on 2003-06-06. The listed applicant is Bionicare Medical Technologies, Inc.. The 510(k) number is K030332.

When did MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 receive FDA 510(k) clearance?

MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 received FDA 510(k) clearance on 2003-06-06, under 510(k) number K030332.

Who is the listed applicant for MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000?

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

What is the FDA product code for MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000?

The FDA product code for MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 is NYN.

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Other records listing Bionicare Medical Technologies, 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.

K052625BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000

Related Devices (Code: NYN)

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.

K111557X-FORCESeven Seas Distribtion and Manufacturing, LLCK073386JOINT STIM, MODEL 1000Pain Management TechnologiesK062325RS-4I MUSCLE STIMULATOR FAMILYRs MedicalK052625BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000Bionicare Medical Technologies, Inc.K983228BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000Murray ElectronicsK971437BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000Murray Electronics

Official Source

View on FDA Database →

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

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