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FDA 510(k)

PHOENIX SYSTEM SEVEN.

K-Number: K862592 · 1986-09-16

ApplicantNicolet Biomedical Instruments
Decision Date1986-09-16
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHOENIX SYSTEM SEVEN. is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical Instruments. It received FDA 510(k) clearance on 1986-09-16 under 510(k) number K862592. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOENIX SYSTEM SEVEN.?

PHOENIX SYSTEM SEVEN. is a medical device that received FDA 510(k) clearance on 1986-09-16. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K862592.

When did PHOENIX SYSTEM SEVEN. receive FDA 510(k) clearance?

PHOENIX SYSTEM SEVEN. received FDA 510(k) clearance on 1986-09-16, under 510(k) number K862592.

Who is the listed applicant for PHOENIX SYSTEM SEVEN.?

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

What is the FDA product code for PHOENIX SYSTEM SEVEN.?

The FDA product code for PHOENIX SYSTEM SEVEN. is EWO.

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Other records listing Nicolet Biomedical Instruments as applicant

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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.

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