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FDA 510(k)

SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12

K-Number: K071221 · 2007-09-06

ApplicantAutomedx, Inc.
Decision Date2007-09-06
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 is the device name listed in this FDA 510(k) record. The listed applicant is Automedx, Inc.. It received FDA 510(k) clearance on 2007-09-06 under 510(k) number K071221. 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 SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12?

SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 is a medical device that received FDA 510(k) clearance on 2007-09-06. The listed applicant is Automedx, Inc.. The 510(k) number is K071221.

When did SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 receive FDA 510(k) clearance?

SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 received FDA 510(k) clearance on 2007-09-06, under 510(k) number K071221.

Who is the listed applicant for SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12?

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

What is the FDA product code for SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12?

The FDA product code for SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 is BTL.

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Related Devices (Code: BTL)

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.

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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.

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