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FDA 510(k)

SATELEC PROPHY UNIT PU 2000S

K-Number: K832674 · 1984-03-16

ApplicantSpelna, Inc.
Decision Date1984-03-16
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SATELEC PROPHY UNIT PU 2000S is the device name listed in this FDA 510(k) record. The listed applicant is Spelna, Inc.. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K832674. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATELEC PROPHY UNIT PU 2000S?

SATELEC PROPHY UNIT PU 2000S is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Spelna, Inc.. The 510(k) number is K832674.

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

SATELEC PROPHY UNIT PU 2000S received FDA 510(k) clearance on 1984-03-16, under 510(k) number K832674.

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

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 2000S?

The FDA product code for SATELEC PROPHY UNIT PU 2000S is ELC.

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Other records listing Spelna, Inc. 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.

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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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