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FDA 510(k)

NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)

K-Number: K872871 · 1987-10-16

ApplicantLabeltape Meditect, Inc.
Decision Date1987-10-16
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR) is the device name listed in this FDA 510(k) record. The listed applicant is Labeltape Meditect, Inc.. It received FDA 510(k) clearance on 1987-10-16 under 510(k) number K872871. 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 NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)?

NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR) is a medical device that received FDA 510(k) clearance on 1987-10-16. The listed applicant is Labeltape Meditect, Inc.. The 510(k) number is K872871.

When did NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR) receive FDA 510(k) clearance?

NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR) received FDA 510(k) clearance on 1987-10-16, under 510(k) number K872871.

Who is the listed applicant for NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)?

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

What is the FDA product code for NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)?

The FDA product code for NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR) is DRX.

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Related Devices (Code: DRX)

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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