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FDA 510(k)

PENLON AM1000 ANAESTHESIA MACHINE

K-Number: K844008 · 1985-03-12

ApplicantPenlon, Inc.
Decision Date1985-03-12
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PENLON AM1000 ANAESTHESIA MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Penlon, Inc.. It received FDA 510(k) clearance on 1985-03-12 under 510(k) number K844008. 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 PENLON AM1000 ANAESTHESIA MACHINE?

PENLON AM1000 ANAESTHESIA MACHINE is a medical device that received FDA 510(k) clearance on 1985-03-12. The listed applicant is Penlon, Inc.. The 510(k) number is K844008.

When did PENLON AM1000 ANAESTHESIA MACHINE receive FDA 510(k) clearance?

PENLON AM1000 ANAESTHESIA MACHINE received FDA 510(k) clearance on 1985-03-12, under 510(k) number K844008.

Who is the listed applicant for PENLON AM1000 ANAESTHESIA MACHINE?

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 PENLON AM1000 ANAESTHESIA MACHINE?

The FDA product code for PENLON AM1000 ANAESTHESIA MACHINE is BSZ.

Related Clinical Trials

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Other records listing Penlon, 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.

K936046SIGMA ELITEK902381PENLON BREATHING SYSTEM PRESSURE MONITORK894689PENLON IDP PRESSURE FAILURE ALARMK844007PENLON PPV VAPORIZERK823555MAGTARAK RESPIRATORY MONITOR & FLOW SENSK803052NUFFIELD ANESTHESIA VENTILATOR SER. 400

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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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