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FDA 510(k)

SATELEC PROPHY UNIT PU-2000

K-Number: K832673 · 1983-10-19

ApplicantSpelna, Inc.
Decision Date1983-10-19
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SATELEC PROPHY UNIT PU-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Spelna, Inc.. It received FDA 510(k) clearance on 1983-10-19 under 510(k) number K832673. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATELEC PROPHY UNIT PU-2000?

SATELEC PROPHY UNIT PU-2000 is a medical device that received FDA 510(k) clearance on 1983-10-19. The listed applicant is Spelna, Inc.. The 510(k) number is K832673.

When did SATELEC PROPHY UNIT PU-2000 receive FDA 510(k) clearance?

SATELEC PROPHY UNIT PU-2000 received FDA 510(k) clearance on 1983-10-19, under 510(k) number K832673.

Who is the listed applicant for SATELEC PROPHY UNIT PU-2000?

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

What is the FDA product code for SATELEC PROPHY UNIT PU-2000?

The FDA product code for SATELEC PROPHY UNIT PU-2000 is EIA.

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Other records listing Spelna, Inc. as applicant

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Related Devices (Code: EIA)

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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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