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FDA 510(k)

DATUM

K-Number: K942799 · 1995-04-13

ApplicantBlease USA, Inc.
Decision Date1995-04-13
Product CodeCAD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DATUM is the device name listed in this FDA 510(k) record. The listed applicant is Blease USA, Inc.. It received FDA 510(k) clearance on 1995-04-13 under 510(k) number K942799. 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 DATUM?

DATUM is a medical device that received FDA 510(k) clearance on 1995-04-13. The listed applicant is Blease USA, Inc.. The 510(k) number is K942799.

When did DATUM receive FDA 510(k) clearance?

DATUM received FDA 510(k) clearance on 1995-04-13, under 510(k) number K942799.

Who is the listed applicant for DATUM?

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

What is the FDA product code for DATUM?

The FDA product code for DATUM 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 Blease USA, 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.

K051629BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000

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 LimitedK053564KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454Penlon LimitedK051666GAV - GENERAL ANAESTHETIC VAPORIZERGeneral Anaesthetic Services Limited

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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