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FDA 510(k)

MASK, PXYGEN

K-Number: K781413 · 1978-09-07

ApplicantVitalab Products Corp.
Decision Date1978-09-07
Product CodeDPT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MASK, PXYGEN is the device name listed in this FDA 510(k) record. The listed applicant is Vitalab Products Corp.. It received FDA 510(k) clearance on 1978-09-07 under 510(k) number K781413. The device is classified under product code DPT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASK, PXYGEN?

MASK, PXYGEN is a medical device that received FDA 510(k) clearance on 1978-09-07. The listed applicant is Vitalab Products Corp.. The 510(k) number is K781413.

When did MASK, PXYGEN receive FDA 510(k) clearance?

MASK, PXYGEN received FDA 510(k) clearance on 1978-09-07, under 510(k) number K781413.

Who is the listed applicant for MASK, PXYGEN?

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

What is the FDA product code for MASK, PXYGEN?

The FDA product code for MASK, PXYGEN is DPT.

Related Clinical Trials

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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Other records listing Vitalab Products 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.

K781416TUBING, FLEXIBLE, MEDICAL GASK781415CANNULA, NASAL, OXYGENK781414MASK, OXYGEN, NONBREATHING

Related Devices (Code: DPT)

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.

K233076Laser Speckle Imaging System (RFLSI CZW)Rwd Life Science Co., Ltd.K163339SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0Spectralmd, Inc.K152749moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imagerMoor Instruments, Ltd.K124049DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEMSpectralmd, Inc.K123216AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE ANAimago SAK122943MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGERMoor Instruments, Ltd.

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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