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FDA 510(k)

PATIENT ISOLATOR #S-10/D-10

K-Number: K820566 · 1982-03-23

ApplicantMicroelectrodes, Inc.
Decision Date1982-03-23
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PATIENT ISOLATOR #S-10/D-10 is the device name listed in this FDA 510(k) record. The listed applicant is Microelectrodes, Inc.. It received FDA 510(k) clearance on 1982-03-23 under 510(k) number K820566. The device is classified under product code FFT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENT ISOLATOR #S-10/D-10?

PATIENT ISOLATOR #S-10/D-10 is a medical device that received FDA 510(k) clearance on 1982-03-23. The listed applicant is Microelectrodes, Inc.. The 510(k) number is K820566.

When did PATIENT ISOLATOR #S-10/D-10 receive FDA 510(k) clearance?

PATIENT ISOLATOR #S-10/D-10 received FDA 510(k) clearance on 1982-03-23, under 510(k) number K820566.

Who is the listed applicant for PATIENT ISOLATOR #S-10/D-10?

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

What is the FDA product code for PATIENT ISOLATOR #S-10/D-10?

The FDA product code for PATIENT ISOLATOR #S-10/D-10 is FFT.

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Related Devices (Code: FFT)

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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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