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FDA 510(k)

PERRY SV-1 HYPERBARIC VENTILATOR

K-Number: K895513 · 1990-12-19

ApplicantPerry Baromedical Services
Decision Date1990-12-19
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PERRY SV-1 HYPERBARIC VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Perry Baromedical Services. It received FDA 510(k) clearance on 1990-12-19 under 510(k) number K895513. 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 PERRY SV-1 HYPERBARIC VENTILATOR?

PERRY SV-1 HYPERBARIC VENTILATOR is a medical device that received FDA 510(k) clearance on 1990-12-19. The listed applicant is Perry Baromedical Services. The 510(k) number is K895513.

When did PERRY SV-1 HYPERBARIC VENTILATOR receive FDA 510(k) clearance?

PERRY SV-1 HYPERBARIC VENTILATOR received FDA 510(k) clearance on 1990-12-19, under 510(k) number K895513.

Who is the listed applicant for PERRY SV-1 HYPERBARIC VENTILATOR?

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

What is the FDA product code for PERRY SV-1 HYPERBARIC VENTILATOR?

The FDA product code for PERRY SV-1 HYPERBARIC VENTILATOR is CBK.

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 Perry Baromedical Services 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.

K983648SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEMK930748SIGMA MP MULTIPLACE HYPERBARIC CHAMBERK862198SIGMA II - DUAL PLACE HYPERBARIC CHAMBER

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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