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FDA 510(k)

APEX MEDICAL XT1 CPAP, MODEL 9S-005

K-Number: K070609 · 2007-05-04

ApplicantApex Medical Corp.
Decision Date2007-05-04
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

APEX MEDICAL XT1 CPAP, MODEL 9S-005 is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical Corp.. It received FDA 510(k) clearance on 2007-05-04 under 510(k) number K070609. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEX MEDICAL XT1 CPAP, MODEL 9S-005?

APEX MEDICAL XT1 CPAP, MODEL 9S-005 is a medical device that received FDA 510(k) clearance on 2007-05-04. The listed applicant is Apex Medical Corp.. The 510(k) number is K070609.

When did APEX MEDICAL XT1 CPAP, MODEL 9S-005 receive FDA 510(k) clearance?

APEX MEDICAL XT1 CPAP, MODEL 9S-005 received FDA 510(k) clearance on 2007-05-04, under 510(k) number K070609.

Who is the listed applicant for APEX MEDICAL XT1 CPAP, MODEL 9S-005?

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

What is the FDA product code for APEX MEDICAL XT1 CPAP, MODEL 9S-005?

The FDA product code for APEX MEDICAL XT1 CPAP, MODEL 9S-005 is BZD.

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Other records listing Apex Medical 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.

K213577VenAir, Sequential Compression SystemK193206WiZARD 510 Nasal MaskK182394WiZARD 310/320 Series CPAP MaskK121642WIZARD 230 NASAL PILOW MASKK112079APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720K120035APEX MEDICAL ICH CPAP SERIES (9S-007XXX)

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Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

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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