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FDA 510(k)

PULSE CUFF RECORDER MODEL PCR100

K-Number: K863702 · 1987-06-12

ApplicantImex Medical Systems, Inc.
Decision Date1987-06-12
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSE CUFF RECORDER MODEL PCR100 is the device name listed in this FDA 510(k) record. The listed applicant is Imex Medical Systems, Inc.. It received FDA 510(k) clearance on 1987-06-12 under 510(k) number K863702. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSE CUFF RECORDER MODEL PCR100?

PULSE CUFF RECORDER MODEL PCR100 is a medical device that received FDA 510(k) clearance on 1987-06-12. The listed applicant is Imex Medical Systems, Inc.. The 510(k) number is K863702.

When did PULSE CUFF RECORDER MODEL PCR100 receive FDA 510(k) clearance?

PULSE CUFF RECORDER MODEL PCR100 received FDA 510(k) clearance on 1987-06-12, under 510(k) number K863702.

Who is the listed applicant for PULSE CUFF RECORDER MODEL PCR100?

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

What is the FDA product code for PULSE CUFF RECORDER MODEL PCR100?

The FDA product code for PULSE CUFF RECORDER MODEL PCR100 is JOM.

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Other records listing Imex Medical Systems, Inc. as applicant

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K973556IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000K973562IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100K973336IMEX STETHODOPK970156IMEX FUTURALDOP PROK942243IMEX 8000 PERSONAL CASCULAR LABK944196IMWXDOP IR

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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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