FDA 510(k)

PC FLOW +

K-Number: K001528 · 2001-01-18

ApplicantSpirometrics Medical Equipment Co.

Decision Date2001-01-18

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PC FLOW + is the device name listed in this FDA 510(k) record. The listed applicant is Spirometrics Medical Equipment Co.. It received FDA 510(k) clearance on 2001-01-18 under 510(k) number K001528. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PC FLOW +?

PC FLOW + is a medical device that received FDA 510(k) clearance on 2001-01-18. The listed applicant is Spirometrics Medical Equipment Co.. The 510(k) number is K001528.

When did PC FLOW + receive FDA 510(k) clearance?

PC FLOW + received FDA 510(k) clearance on 2001-01-18, under 510(k) number K001528.

Who is the listed applicant for PC FLOW +?

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

What is the FDA product code for PC FLOW +?

The FDA product code for PC FLOW + is BZG.

Other records listing Spirometrics Medical Equipment 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.

K982956FLOWMATE II PLUS, MODEL #4000 K954759FLOWMATE LTE

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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.