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FDA 510(k)

CAREDOP II

K-Number: K982635 · 1998-08-07

ApplicantNicolet Biomedical
Decision Date1998-08-07
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAREDOP II is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical. It received FDA 510(k) clearance on 1998-08-07 under 510(k) number K982635. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAREDOP II?

CAREDOP II is a medical device that received FDA 510(k) clearance on 1998-08-07. The listed applicant is Nicolet Biomedical. The 510(k) number is K982635.

When did CAREDOP II receive FDA 510(k) clearance?

CAREDOP II received FDA 510(k) clearance on 1998-08-07, under 510(k) number K982635.

Who is the listed applicant for CAREDOP II?

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

What is the FDA product code for CAREDOP II?

The FDA product code for CAREDOP II is JAF.

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Other records listing Nicolet Biomedical 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.

K020754NICOLET PIONEER TC8080K013281VERSALAB APMK013419NICOLET ELECTROMAGNETIC NAVIGATION SYSTEMK011135GSI AUDERAK010521NICOLET VERSALABK002766NICOLET VASOGUARD

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Related Devices (Code: JAF)

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.

K242487Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc.K110628SIMPLEABINewman MedicalK093393LIFEDOP MODEL 300ABISummit Doppler Systems, Inc.K090009THD SLIDE ONEThd SpaK081429THD SLIDEThd SpaK070815THDG.F. S.R.L.

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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