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FDA 510(k)

PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200

K-Number: K000206 · 2000-04-13

ApplicantAxelgaard Mfg. Co., Ltd.
Decision Date2000-04-13
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 is the device name listed in this FDA 510(k) record. The listed applicant is Axelgaard Mfg. Co., Ltd.. It received FDA 510(k) clearance on 2000-04-13 under 510(k) number K000206. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200?

PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 is a medical device that received FDA 510(k) clearance on 2000-04-13. The listed applicant is Axelgaard Mfg. Co., Ltd.. The 510(k) number is K000206.

When did PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 receive FDA 510(k) clearance?

PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 received FDA 510(k) clearance on 2000-04-13, under 510(k) number K000206.

Who is the listed applicant for PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200?

The FDA 510(k) record lists Axelgaard Mfg. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200?

The FDA product code for PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 is DRX.

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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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