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FDA 510(k)

KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454

K-Number: K053564 · 2006-03-03

ApplicantPenlon Limited
Decision Date2006-03-03
Product CodeCAD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 is the device name listed in this FDA 510(k) record. The listed applicant is Penlon Limited. It received FDA 510(k) clearance on 2006-03-03 under 510(k) number K053564. The device is classified under product code CAD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454?

KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 is a medical device that received FDA 510(k) clearance on 2006-03-03. The listed applicant is Penlon Limited. The 510(k) number is K053564.

When did KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 receive FDA 510(k) clearance?

KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 received FDA 510(k) clearance on 2006-03-03, under 510(k) number K053564.

Who is the listed applicant for KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454?

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

What is the FDA product code for KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454?

The FDA product code for KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 is CAD.

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 Penlon Limited 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.

K060331SIGMA ALPHA VAPORIZERK051222AV-S ANAESTHESIA VENTILATOR

Related Devices (Code: CAD)

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.

K240375V80 Anesthetic Vaporizer (V80)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K172702Tec 820, Tec 850Datex-Ohmeda, Inc.K110608SEVOFLURANE VAPORIZER ADAPTORPiramal Critcal Care, Inc (Formerly Minrad, Inc)K060331SIGMA ALPHA VAPORIZERPenlon LimitedK051666GAV - GENERAL ANAESTHETIC VAPORIZERGeneral Anaesthetic Services LimitedK042276D-VAPORDraeger Medical, Inc.

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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