FDA 510(k)

EMS/400

K-Number: K913272 · 1991-08-22

Decision Date1991-08-22

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

EMS/400 is the device name listed in this FDA 510(k) record. The listed applicant is Altoona Medical Supply. It received FDA 510(k) clearance on 1991-08-22 under 510(k) number K913272. 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 EMS/400?

EMS/400 is a medical device that received FDA 510(k) clearance on 1991-08-22. The listed applicant is Altoona Medical Supply. The 510(k) number is K913272.

When did EMS/400 receive FDA 510(k) clearance?

EMS/400 received FDA 510(k) clearance on 1991-08-22, under 510(k) number K913272.

Who is the listed applicant for EMS/400?

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

What is the FDA product code for EMS/400?

The FDA product code for EMS/400 is IPF.

Other records listing Altoona Medical Supply 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.

K921711FLEXION DISTRATION SUPPORT K893874FUJITENS III

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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.