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FDA 510(k)

BACPAC (TM), MODEL 6500

K-Number: K864968 · 1987-03-13

ApplicantMedical Devices, Inc.
Decision Date1987-03-13
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BACPAC (TM), MODEL 6500 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 1987-03-13 under 510(k) number K864968. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACPAC (TM), MODEL 6500?

BACPAC (TM), MODEL 6500 is a medical device that received FDA 510(k) clearance on 1987-03-13. The listed applicant is Medical Devices, Inc.. The 510(k) number is K864968.

When did BACPAC (TM), MODEL 6500 receive FDA 510(k) clearance?

BACPAC (TM), MODEL 6500 received FDA 510(k) clearance on 1987-03-13, under 510(k) number K864968.

Who is the listed applicant for BACPAC (TM), MODEL 6500?

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

What is the FDA product code for BACPAC (TM), MODEL 6500?

The FDA product code for BACPAC (TM), MODEL 6500 is GZJ.

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Other records listing Medical Devices, Inc. as applicant

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Related Devices (Code: GZJ)

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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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