FDA 510(k)

SATLEC PROPHY UNIT PU 3055

K-Number: K852521 · 1985-07-31

Decision Date1985-07-31

Product CodeKOJ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SATLEC PROPHY UNIT PU 3055 is the device name listed in this FDA 510(k) record. The listed applicant is Spelna, Inc.. It received FDA 510(k) clearance on 1985-07-31 under 510(k) number K852521. The device is classified under product code KOJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATLEC PROPHY UNIT PU 3055?

SATLEC PROPHY UNIT PU 3055 is a medical device that received FDA 510(k) clearance on 1985-07-31. The listed applicant is Spelna, Inc.. The 510(k) number is K852521.

When did SATLEC PROPHY UNIT PU 3055 receive FDA 510(k) clearance?

SATLEC PROPHY UNIT PU 3055 received FDA 510(k) clearance on 1985-07-31, under 510(k) number K852521.

Who is the listed applicant for SATLEC PROPHY UNIT PU 3055?

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 SATLEC PROPHY UNIT PU 3055?

The FDA product code for SATLEC PROPHY UNIT PU 3055 is KOJ.

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Other records listing Spelna, Inc. as applicant

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Related Devices (Code: KOJ)

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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.