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FDA 510(k)

AUTOVENT 4000 WITH CPAP

K-Number: K070636 · 2007-07-13

ApplicantAllied Healthcare Products, Inc.
Decision Date2007-07-13
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTOVENT 4000 WITH CPAP is the device name listed in this FDA 510(k) record. The listed applicant is Allied Healthcare Products, Inc.. It received FDA 510(k) clearance on 2007-07-13 under 510(k) number K070636. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOVENT 4000 WITH CPAP?

AUTOVENT 4000 WITH CPAP is a medical device that received FDA 510(k) clearance on 2007-07-13. The listed applicant is Allied Healthcare Products, Inc.. The 510(k) number is K070636.

When did AUTOVENT 4000 WITH CPAP receive FDA 510(k) clearance?

AUTOVENT 4000 WITH CPAP received FDA 510(k) clearance on 2007-07-13, under 510(k) number K070636.

Who is the listed applicant for AUTOVENT 4000 WITH CPAP?

The FDA 510(k) record lists Allied Healthcare Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOVENT 4000 WITH CPAP?

The FDA product code for AUTOVENT 4000 WITH CPAP is BTL.

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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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