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FDA 510(k)

SUPRASSON P5 BOOSTER

K-Number: K961158 · 1996-05-23

ApplicantSatelec
Decision Date1996-05-23
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUPRASSON P5 BOOSTER is the device name listed in this FDA 510(k) record. The listed applicant is Satelec. It received FDA 510(k) clearance on 1996-05-23 under 510(k) number K961158. 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 SUPRASSON P5 BOOSTER?

SUPRASSON P5 BOOSTER is a medical device that received FDA 510(k) clearance on 1996-05-23. The listed applicant is Satelec. The 510(k) number is K961158.

When did SUPRASSON P5 BOOSTER receive FDA 510(k) clearance?

SUPRASSON P5 BOOSTER received FDA 510(k) clearance on 1996-05-23, under 510(k) number K961158.

Who is the listed applicant for SUPRASSON P5 BOOSTER?

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

What is the FDA product code for SUPRASSON P5 BOOSTER?

The FDA product code for SUPRASSON P5 BOOSTER is ELC.

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Other records listing Satelec as applicant

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Related Devices (Code: ELC)

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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