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FDA 510(k)

NOVO BMC-LAB 23, BONE DENSITOMETER

K-Number: K864299 · 1987-11-12

ApplicantScan Detectronic Laboratories, Inc.
Decision Date1987-11-12
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NOVO BMC-LAB 23, BONE DENSITOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Scan Detectronic Laboratories, Inc.. It received FDA 510(k) clearance on 1987-11-12 under 510(k) number K864299. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVO BMC-LAB 23, BONE DENSITOMETER?

NOVO BMC-LAB 23, BONE DENSITOMETER is a medical device that received FDA 510(k) clearance on 1987-11-12. The listed applicant is Scan Detectronic Laboratories, Inc.. The 510(k) number is K864299.

When did NOVO BMC-LAB 23, BONE DENSITOMETER receive FDA 510(k) clearance?

NOVO BMC-LAB 23, BONE DENSITOMETER received FDA 510(k) clearance on 1987-11-12, under 510(k) number K864299.

Who is the listed applicant for NOVO BMC-LAB 23, BONE DENSITOMETER?

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

What is the FDA product code for NOVO BMC-LAB 23, BONE DENSITOMETER?

The FDA product code for NOVO BMC-LAB 23, BONE DENSITOMETER is KGI.

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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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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