Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PORTA-RESP MONITOR

K-Number: K943146 · 1994-11-28

ApplicantS & M Instrument Co.
Decision Date1994-11-28
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTA-RESP MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is S & M Instrument Co.. It received FDA 510(k) clearance on 1994-11-28 under 510(k) number K943146. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTA-RESP MONITOR?

PORTA-RESP MONITOR is a medical device that received FDA 510(k) clearance on 1994-11-28. The listed applicant is S & M Instrument Co.. The 510(k) number is K943146.

When did PORTA-RESP MONITOR receive FDA 510(k) clearance?

PORTA-RESP MONITOR received FDA 510(k) clearance on 1994-11-28, under 510(k) number K943146.

Who is the listed applicant for PORTA-RESP MONITOR?

The FDA 510(k) record lists S & M Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTA-RESP MONITOR?

The FDA product code for PORTA-RESP MONITOR is CAP.

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 S & M Instrument Co. 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.

K951367PORTA-SCREEN SPIROMETERK920877THE KEYSTONE SYSTEMK884051DSM-1 DOSIMETER

Related Devices (Code: CAP)

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.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCK153733VORTRAN ManometerVortran Medical Technology 1, Inc.K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.

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.

↑