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)

STAODYN EMS+2

K-Number: K926510 · 1993-08-11

Decision Date1993-08-11
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STAODYN EMS+2 is the device name listed in this FDA 510(k) record. The listed applicant is Staodyne, Inc.. It received FDA 510(k) clearance on 1993-08-11 under 510(k) number K926510. 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 STAODYN EMS+2?

STAODYN EMS+2 is a medical device that received FDA 510(k) clearance on 1993-08-11. The listed applicant is Staodyne, Inc.. The 510(k) number is K926510.

When did STAODYN EMS+2 receive FDA 510(k) clearance?

STAODYN EMS+2 received FDA 510(k) clearance on 1993-08-11, under 510(k) number K926510.

Who is the listed applicant for STAODYN EMS+2?

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

What is the FDA product code for STAODYN EMS+2?

The FDA product code for STAODYN EMS+2 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 Staodyne, 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.

View all 9 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.

↑