Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000

K-Number: K971437 · 1997-07-22

ApplicantMurray Electronics
Decision Date1997-07-22
Product CodeNYN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Murray Electronics. It received FDA 510(k) clearance on 1997-07-22 under 510(k) number K971437. 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 BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000?

BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 is a medical device that received FDA 510(k) clearance on 1997-07-22. The listed applicant is Murray Electronics. The 510(k) number is K971437.

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

BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 received FDA 510(k) clearance on 1997-07-22, under 510(k) number K971437.

Who is the listed applicant for BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000?

The FDA 510(k) record lists Murray Electronics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000?

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

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Murray Electronics 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.

K983228BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000K832805BIONICARE STIMULATOR BIO-1

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.K030332MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000Bionicare Medical Technologies, Inc.K983228BIONICARE STIMILATOR 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.

↑