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FDA 510(k)

PA-1 LOW PRESSURE ALARM

K-Number: K802112 · 1980-09-06

ApplicantPuritan Bennett Corp.
Decision Date1980-09-06
Product Code
DecisionSubstantially Equivalent

Device Summary

PA-1 LOW PRESSURE ALARM is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Bennett Corp.. It received FDA 510(k) clearance on 1980-09-06 under 510(k) number K802112. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PA-1 LOW PRESSURE ALARM?

PA-1 LOW PRESSURE ALARM is a medical device that received FDA 510(k) clearance on 1980-09-06. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K802112.

When did PA-1 LOW PRESSURE ALARM receive FDA 510(k) clearance?

PA-1 LOW PRESSURE ALARM received FDA 510(k) clearance on 1980-09-06, under 510(k) number K802112.

Who is the listed applicant for PA-1 LOW PRESSURE ALARM?

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

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Other records listing Puritan Bennett Corp. 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.

K063650VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840K053388MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTIONK023225PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWAREK022103PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEMK001646PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTIONK002001BREEZE SLEEPGEAR WITH DREAMSEAL

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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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