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FDA 510(k)

PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR

K-Number: K892886 · 1989-10-27

ApplicantPercussionaire Corp.
Decision Date1989-10-27
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Percussionaire Corp.. It received FDA 510(k) clearance on 1989-10-27 under 510(k) number K892886. 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 PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR?

PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR is a medical device that received FDA 510(k) clearance on 1989-10-27. The listed applicant is Percussionaire Corp.. The 510(k) number is K892886.

When did PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR receive FDA 510(k) clearance?

PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR received FDA 510(k) clearance on 1989-10-27, under 510(k) number K892886.

Who is the listed applicant for PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR?

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

What is the FDA product code for PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR?

The FDA product code for PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR is CBK.

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Other records listing Percussionaire 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.

K905234TXP TRANSPORTER FAMILY AND RELATED ACCESSORIESK905235VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESSK905236IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIESK900313PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MINK900315PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MINK900314PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN

View all 11 devices →

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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