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FDA 510(k)

APNEA ALARM FOR ADULT-PEDIATRIC & NEON

K-Number: K831601 · 1983-09-26

ApplicantPlasmedics, Inc.
Decision Date1983-09-26
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

APNEA ALARM FOR ADULT-PEDIATRIC & NEON is the device name listed in this FDA 510(k) record. The listed applicant is Plasmedics, Inc.. It received FDA 510(k) clearance on 1983-09-26 under 510(k) number K831601. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APNEA ALARM FOR ADULT-PEDIATRIC & NEON?

APNEA ALARM FOR ADULT-PEDIATRIC & NEON is a medical device that received FDA 510(k) clearance on 1983-09-26. The listed applicant is Plasmedics, Inc.. The 510(k) number is K831601.

When did APNEA ALARM FOR ADULT-PEDIATRIC & NEON receive FDA 510(k) clearance?

APNEA ALARM FOR ADULT-PEDIATRIC & NEON received FDA 510(k) clearance on 1983-09-26, under 510(k) number K831601.

Who is the listed applicant for APNEA ALARM FOR ADULT-PEDIATRIC & NEON?

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

What is the FDA product code for APNEA ALARM FOR ADULT-PEDIATRIC & NEON?

The FDA product code for APNEA ALARM FOR ADULT-PEDIATRIC & NEON is BZQ.

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Other records listing Plasmedics, 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.

K853559STERILE BIOPSY NEEDLESK850263PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLYK831650ANESTHESIA/RESPIRATORY DISCONNECT -K830604WEDGE PRESSURE CATHETERK823351CENTRAL VENOUS CATHETER

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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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