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FDA 510(k)

NUFFIELD ANESTHESIA VENTILATOR SER. 400

K-Number: K803052 · 1981-01-07

ApplicantPenlon, Inc.
Decision Date1981-01-07
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NUFFIELD ANESTHESIA VENTILATOR SER. 400 is the device name listed in this FDA 510(k) record. The listed applicant is Penlon, Inc.. It received FDA 510(k) clearance on 1981-01-07 under 510(k) number K803052. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUFFIELD ANESTHESIA VENTILATOR SER. 400?

NUFFIELD ANESTHESIA VENTILATOR SER. 400 is a medical device that received FDA 510(k) clearance on 1981-01-07. The listed applicant is Penlon, Inc.. The 510(k) number is K803052.

When did NUFFIELD ANESTHESIA VENTILATOR SER. 400 receive FDA 510(k) clearance?

NUFFIELD ANESTHESIA VENTILATOR SER. 400 received FDA 510(k) clearance on 1981-01-07, under 510(k) number K803052.

Who is the listed applicant for NUFFIELD ANESTHESIA VENTILATOR SER. 400?

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

What is the FDA product code for NUFFIELD ANESTHESIA VENTILATOR SER. 400?

The FDA product code for NUFFIELD ANESTHESIA VENTILATOR SER. 400 is BSZ.

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Other records listing Penlon, Inc. as applicant

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Related Devices (Code: BSZ)

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.

K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)Drägerwerk AG Co. KgaaK251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)Codonics.IncorporatedK230931AtlanDrägerwerk AG Co. KgaaK213867Carestation 750/750cDatex-Ohmeda, Inc.K201957A8, A9 Anesthesia SystemShenzhen 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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