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FDA 510(k)

PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

K-Number: K070594 · 2007-08-01

ApplicantPulmonetic Systems, Inc.
Decision Date2007-08-01
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonetic Systems, Inc.. It received FDA 510(k) clearance on 2007-08-01 under 510(k) number K070594. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALMTOP VENTILATOR, MODELS PTV-8, PTV-10?

PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 is a medical device that received FDA 510(k) clearance on 2007-08-01. The listed applicant is Pulmonetic Systems, Inc.. The 510(k) number is K070594.

When did PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 receive FDA 510(k) clearance?

PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 received FDA 510(k) clearance on 2007-08-01, under 510(k) number K070594.

Who is the listed applicant for PALMTOP VENTILATOR, MODELS PTV-8, PTV-10?

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

What is the FDA product code for PALMTOP VENTILATOR, MODELS PTV-8, PTV-10?

The FDA product code for PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 is CBK.

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Other records listing Pulmonetic Systems, Inc. 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.

K083688PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATORK060647LTV 1200 VENTILATORK060549AUTOMOBILE LIGHTER POWER CORDK051767LTV 1000 VENTILATORK040790MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITSK040540MODIFICATION TO LTV 1000 VENTILATOR

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Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics 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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