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FDA 510(k)

NEONATAL BREATHING CIRCUIT MODIFICATION

K-Number: K932288 · 1994-12-30

ApplicantSimplex Medical Systems, Inc.
Decision Date1994-12-30
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEONATAL BREATHING CIRCUIT MODIFICATION 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 1994-12-30 under 510(k) number K932288. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEONATAL BREATHING CIRCUIT MODIFICATION?

NEONATAL BREATHING CIRCUIT MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-12-30. The listed applicant is Simplex Medical Systems, Inc.. The 510(k) number is K932288.

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

NEONATAL BREATHING CIRCUIT MODIFICATION received FDA 510(k) clearance on 1994-12-30, under 510(k) number K932288.

Who is the listed applicant for NEONATAL BREATHING CIRCUIT MODIFICATION?

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 NEONATAL BREATHING CIRCUIT MODIFICATION?

The FDA product code for NEONATAL BREATHING CIRCUIT MODIFICATION is CAI.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 AIRBRATORK904396SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM

Related Devices (Code: CAI)

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.

K954480CONDENSATE COLLECTION KITNova-VentrxK953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.K952018PRIMA COAXIAL CIRCUITSPrima, Inc.K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, Inc.

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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