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FDA 510(k)

ANESTHESIA APPARATUS PH-35

K-Number: K830159 · 1983-03-09

ApplicantW.E. Leder Enterprises, Inc.
Decision Date1983-03-09
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ANESTHESIA APPARATUS PH-35 is the device name listed in this FDA 510(k) record. The listed applicant is W.E. Leder Enterprises, Inc.. It received FDA 510(k) clearance on 1983-03-09 under 510(k) number K830159. 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 ANESTHESIA APPARATUS PH-35?

ANESTHESIA APPARATUS PH-35 is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is W.E. Leder Enterprises, Inc.. The 510(k) number is K830159.

When did ANESTHESIA APPARATUS PH-35 receive FDA 510(k) clearance?

ANESTHESIA APPARATUS PH-35 received FDA 510(k) clearance on 1983-03-09, under 510(k) number K830159.

Who is the listed applicant for ANESTHESIA APPARATUS PH-35?

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

What is the FDA product code for ANESTHESIA APPARATUS PH-35?

The FDA product code for ANESTHESIA APPARATUS PH-35 is BSZ.

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Other records listing W.E. Leder Enterprises, 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.

K831877ARF 850 EK831981LARYNGESCOPEK831878CARDIO-SCOPE MINI MONITORK830161ANESTHESIA APATATUS #D-25K830160ANESTHESIA APPARATUS #FO 20S

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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