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FDA 510(k)

VENTILATOR SETUP, VOLUME

K-Number: K772070 · 1977-11-15

ApplicantInspiron Corp.
Decision Date1977-11-15
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTILATOR SETUP, VOLUME is the device name listed in this FDA 510(k) record. The listed applicant is Inspiron Corp.. It received FDA 510(k) clearance on 1977-11-15 under 510(k) number K772070. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTILATOR SETUP, VOLUME?

VENTILATOR SETUP, VOLUME is a medical device that received FDA 510(k) clearance on 1977-11-15. The listed applicant is Inspiron Corp.. The 510(k) number is K772070.

When did VENTILATOR SETUP, VOLUME receive FDA 510(k) clearance?

VENTILATOR SETUP, VOLUME received FDA 510(k) clearance on 1977-11-15, under 510(k) number K772070.

Who is the listed applicant for VENTILATOR SETUP, VOLUME?

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

What is the FDA product code for VENTILATOR SETUP, VOLUME?

The FDA product code for VENTILATOR SETUP, VOLUME is CAF.

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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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