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FDA 510(k)

RESPIRATOR DISCONNECT ALARM CR 201

K-Number: K792516 · 1980-01-09

ApplicantIntersect Medical Products, Inc.
Decision Date1980-01-09
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATOR DISCONNECT ALARM CR 201 is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Medical Products, Inc.. It received FDA 510(k) clearance on 1980-01-09 under 510(k) number K792516. 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 RESPIRATOR DISCONNECT ALARM CR 201?

RESPIRATOR DISCONNECT ALARM CR 201 is a medical device that received FDA 510(k) clearance on 1980-01-09. The listed applicant is Intersect Medical Products, Inc.. The 510(k) number is K792516.

When did RESPIRATOR DISCONNECT ALARM CR 201 receive FDA 510(k) clearance?

RESPIRATOR DISCONNECT ALARM CR 201 received FDA 510(k) clearance on 1980-01-09, under 510(k) number K792516.

Who is the listed applicant for RESPIRATOR DISCONNECT ALARM CR 201?

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

What is the FDA product code for RESPIRATOR DISCONNECT ALARM CR 201?

The FDA product code for RESPIRATOR DISCONNECT ALARM CR 201 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 Intersect Medical Products, 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.

K945543GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONEK792515RESPIRATOR DISCONNECT ALARMK791561RESPIRATOR DISCONNECT ALARM VA-100K791527RESPIRATOR DISCONNECT ALARM CR201

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.

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