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FDA 510(k)

WALKCARE P200 SYSTEM

K-Number: K973592 · 1999-05-20

ApplicantA.Stein - Regulatory Affairs Consulting
Decision Date1999-05-20
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WALKCARE P200 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is A.Stein - Regulatory Affairs Consulting. It received FDA 510(k) clearance on 1999-05-20 under 510(k) number K973592. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALKCARE P200 SYSTEM?

WALKCARE P200 SYSTEM is a medical device that received FDA 510(k) clearance on 1999-05-20. The listed applicant is A.Stein - Regulatory Affairs Consulting. The 510(k) number is K973592.

When did WALKCARE P200 SYSTEM receive FDA 510(k) clearance?

WALKCARE P200 SYSTEM received FDA 510(k) clearance on 1999-05-20, under 510(k) number K973592.

Who is the listed applicant for WALKCARE P200 SYSTEM?

The FDA 510(k) record lists A.Stein - Regulatory Affairs Consulting as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WALKCARE P200 SYSTEM?

The FDA product code for WALKCARE P200 SYSTEM is JOW.

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Other records listing A.Stein - Regulatory Affairs Consulting 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.

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Related Devices (Code: JOW)

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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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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