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FDA 510(k)

SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM

K-Number: K904396 · 1991-03-05

ApplicantSimplex Medical Systems, Inc.
Decision Date1991-03-05
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Simplex Medical Systems, Inc.. It received FDA 510(k) clearance on 1991-03-05 under 510(k) number K904396. 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 SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM?

SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM is a medical device that received FDA 510(k) clearance on 1991-03-05. The listed applicant is Simplex Medical Systems, Inc.. The 510(k) number is K904396.

When did SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM receive FDA 510(k) clearance?

SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM received FDA 510(k) clearance on 1991-03-05, under 510(k) number K904396.

Who is the listed applicant for SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM?

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

What is the FDA product code for SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM?

The FDA product code for SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM is BZQ.

Related Clinical Trials

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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Other records listing Simplex Medical Systems, 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.

K970249SIMPLEX AIRBRATORK932288NEONATAL BREATHING CIRCUIT MODIFICATION

Related Devices (Code: BZQ)

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

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