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FDA 510(k)

PRIMA ANAESTHESIA MACHINE

K-Number: K061102 · 2006-07-28

ApplicantPenlon , Ltd.
Decision Date2006-07-28
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRIMA ANAESTHESIA MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Penlon , Ltd.. It received FDA 510(k) clearance on 2006-07-28 under 510(k) number K061102. 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 PRIMA ANAESTHESIA MACHINE?

PRIMA ANAESTHESIA MACHINE is a medical device that received FDA 510(k) clearance on 2006-07-28. The listed applicant is Penlon , Ltd.. The 510(k) number is K061102.

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

PRIMA ANAESTHESIA MACHINE received FDA 510(k) clearance on 2006-07-28, under 510(k) number K061102.

Who is the listed applicant for PRIMA ANAESTHESIA MACHINE?

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

What is the FDA product code for PRIMA ANAESTHESIA MACHINE?

The FDA product code for PRIMA ANAESTHESIA MACHINE is BSZ.

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Other records listing Penlon , Ltd. 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.

K041076DELTA TK010317AV 800 VENTILATORK010318PRIMA OXYGEN MONITORK002343SIGMA DELTAK961468QUIK-FIL VAPORIZER KEYED FILLERK960944PPV VAPORIZER (MODIFICATION)

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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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