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FDA 510(k)

NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)

K-Number: K904499 · 1991-07-01

ApplicantAckrad Laboratories
Decision Date1991-07-01
Product CodeKFG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Ackrad Laboratories. It received FDA 510(k) clearance on 1991-07-01 under 510(k) number K904499. The device is classified under product code KFG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)?

NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) is a medical device that received FDA 510(k) clearance on 1991-07-01. The listed applicant is Ackrad Laboratories. The 510(k) number is K904499.

When did NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) receive FDA 510(k) clearance?

NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) received FDA 510(k) clearance on 1991-07-01, under 510(k) number K904499.

Who is the listed applicant for NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)?

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

What is the FDA product code for NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)?

The FDA product code for NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) is KFG.

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Other records listing Ackrad Laboratories 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.

K021272SIB CATHETER, MODEL 61-7005K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAYK020951H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007K970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERK961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)K952542ACKRAD ESOPHAGEAL BALLOON CATHETER SET

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Related Devices (Code: KFG)

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.

K792698ASPERGILLUS SP, ANTISERUM, POSITIVEMeridian Diagnostics, Inc.K792686ASPERGILLUS SP, ANTISERUM POSITIVEMeridian Diagnostics, Inc.K791386ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUMImmuno-Mycologics, Inc.K760835ANTI-ASPERGILLUS CONT. SER. (MYCELIAL)I M, 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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