FDA 510(k)

SIM 4000I

K-Number: K873845 · 1988-04-07

ApplicantOte-Biomedica Elettronica S.P.A

Decision Date1988-04-07

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SIM 4000I is the device name listed in this FDA 510(k) record. The listed applicant is Ote-Biomedica Elettronica S.P.A. It received FDA 510(k) clearance on 1988-04-07 under 510(k) number K873845. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIM 4000I?

SIM 4000I is a medical device that received FDA 510(k) clearance on 1988-04-07. The listed applicant is Ote-Biomedica Elettronica S.P.A. The 510(k) number is K873845.

When did SIM 4000I receive FDA 510(k) clearance?

SIM 4000I received FDA 510(k) clearance on 1988-04-07, under 510(k) number K873845.

Who is the listed applicant for SIM 4000I?

The FDA 510(k) record lists Ote-Biomedica Elettronica S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIM 4000I?

The FDA product code for SIM 4000I is IYO.

Other records listing Ote-Biomedica Elettronica S.P.A 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.

K874548SIM 4000C

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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.