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)

RESPOND II...NEUROMUSCULAR STIMULATOR

K-Number: K813008 · 1981-12-02

Decision Date1981-12-02
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

RESPOND II...NEUROMUSCULAR STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1981-12-02 under 510(k) number K813008. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPOND II...NEUROMUSCULAR STIMULATOR?

RESPOND II...NEUROMUSCULAR STIMULATOR is a medical device that received FDA 510(k) clearance on 1981-12-02. The listed applicant is Medtronic Vascular. The 510(k) number is K813008.

When did RESPOND II...NEUROMUSCULAR STIMULATOR receive FDA 510(k) clearance?

RESPOND II...NEUROMUSCULAR STIMULATOR received FDA 510(k) clearance on 1981-12-02, under 510(k) number K813008.

Who is the listed applicant for RESPOND II...NEUROMUSCULAR STIMULATOR?

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

What is the FDA product code for RESPOND II...NEUROMUSCULAR STIMULATOR?

The FDA product code for RESPOND II...NEUROMUSCULAR STIMULATOR is IPF.

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.

Other records listing Medtronic Vascular 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.

View all 474 devices →

Related Devices (Code: IPF)

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.

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.

↑