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FDA 510(k)

PEDI-CAP

K-Number: K944400 · 1994-09-27

ApplicantNellcor, Inc.
Decision Date1994-09-27
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEDI-CAP is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor, Inc.. It received FDA 510(k) clearance on 1994-09-27 under 510(k) number K944400. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDI-CAP?

PEDI-CAP is a medical device that received FDA 510(k) clearance on 1994-09-27. The listed applicant is Nellcor, Inc.. The 510(k) number is K944400.

When did PEDI-CAP receive FDA 510(k) clearance?

PEDI-CAP received FDA 510(k) clearance on 1994-09-27, under 510(k) number K944400.

Who is the listed applicant for PEDI-CAP?

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

What is the FDA product code for PEDI-CAP?

The FDA product code for PEDI-CAP is CCK.

Other records listing Nellcor, 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.

K953472NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITORK952316NELLCOR SYMPHONY N-3000 PULSE OXIMETERK952222NELLCOR N-20PA PORTABLE PULSE OXIMETERK942347NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000K945947NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETERK944760DURA-Y OXYGEN TRANSDUCER, EAR CLIP

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Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, 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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