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FDA 510(k)

PERCUSSIONAIRE RESPIRATORS (MULTIPLE)

K-Number: K884832 · 1989-09-14

ApplicantPercussionaire Corp.
Decision Date1989-09-14
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PERCUSSIONAIRE RESPIRATORS (MULTIPLE) is the device name listed in this FDA 510(k) record. The listed applicant is Percussionaire Corp.. It received FDA 510(k) clearance on 1989-09-14 under 510(k) number K884832. 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 RESPIRATORS (MULTIPLE)?

PERCUSSIONAIRE RESPIRATORS (MULTIPLE) is a medical device that received FDA 510(k) clearance on 1989-09-14. The listed applicant is Percussionaire Corp.. The 510(k) number is K884832.

When did PERCUSSIONAIRE RESPIRATORS (MULTIPLE) receive FDA 510(k) clearance?

PERCUSSIONAIRE RESPIRATORS (MULTIPLE) received FDA 510(k) clearance on 1989-09-14, under 510(k) number K884832.

Who is the listed applicant for PERCUSSIONAIRE RESPIRATORS (MULTIPLE)?

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 RESPIRATORS (MULTIPLE)?

The FDA product code for PERCUSSIONAIRE RESPIRATORS (MULTIPLE) 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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