FDA 510(k)

PA300

K-Number: K942512 · 1994-11-18

Decision Date1994-11-18

Product CodeFRF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PA300 is the device name listed in this FDA 510(k) record. The listed applicant is The Rival Co.. It received FDA 510(k) clearance on 1994-11-18 under 510(k) number K942512. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PA300?

PA300 is a medical device that received FDA 510(k) clearance on 1994-11-18. The listed applicant is The Rival Co.. The 510(k) number is K942512.

When did PA300 receive FDA 510(k) clearance?

PA300 received FDA 510(k) clearance on 1994-11-18, under 510(k) number K942512.

Who is the listed applicant for PA300?

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

What is the FDA product code for PA300?

The FDA product code for PA300 is FRF.

Other records listing The Rival Co. 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.

K930521AIR CLEANERS WITH HEPA FILTRATION

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.