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FDA 510(k)

INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400

K-Number: K011344 · 2002-05-17

ApplicantCollins Medical, Inc.
Decision Date2002-05-17
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 is the device name listed in this FDA 510(k) record. The listed applicant is Collins Medical, Inc.. It received FDA 510(k) clearance on 2002-05-17 under 510(k) number K011344. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400?

INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 is a medical device that received FDA 510(k) clearance on 2002-05-17. The listed applicant is Collins Medical, Inc.. The 510(k) number is K011344.

When did INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 receive FDA 510(k) clearance?

INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 received FDA 510(k) clearance on 2002-05-17, under 510(k) number K011344.

Who is the listed applicant for INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400?

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

What is the FDA product code for INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400?

The FDA product code for INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 is BZC.

Related Clinical Trials

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Other records listing Collins Medical, 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.

K030917GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130K030464GEM, MODEL 004110K992743COLLINS CPL

Related Devices (Code: BZC)

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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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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