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FDA 510(k)

RESTEP DVY SYSTEM, MODEL RSP-101

K-Number: K090308 · 2009-05-01

ApplicantStortford Medical, LLC
Decision Date2009-05-01
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RESTEP DVY SYSTEM, MODEL RSP-101 is the device name listed in this FDA 510(k) record. The listed applicant is Stortford Medical, LLC. It received FDA 510(k) clearance on 2009-05-01 under 510(k) number K090308. 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 RESTEP DVY SYSTEM, MODEL RSP-101?

RESTEP DVY SYSTEM, MODEL RSP-101 is a medical device that received FDA 510(k) clearance on 2009-05-01. The listed applicant is Stortford Medical, LLC. The 510(k) number is K090308.

When did RESTEP DVY SYSTEM, MODEL RSP-101 receive FDA 510(k) clearance?

RESTEP DVY SYSTEM, MODEL RSP-101 received FDA 510(k) clearance on 2009-05-01, under 510(k) number K090308.

Who is the listed applicant for RESTEP DVY SYSTEM, MODEL RSP-101?

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

What is the FDA product code for RESTEP DVY SYSTEM, MODEL RSP-101?

The FDA product code for RESTEP DVY SYSTEM, MODEL RSP-101 is JOW.

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Other records listing Stortford Medical, LLC as applicant

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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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