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FDA 510(k)

BSI MODEL TIP

K-Number: K897191 · 1990-07-13

ApplicantBales Scientific, Inc.
Decision Date1990-07-13
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BSI MODEL TIP is the device name listed in this FDA 510(k) record. The listed applicant is Bales Scientific, Inc.. It received FDA 510(k) clearance on 1990-07-13 under 510(k) number K897191. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BSI MODEL TIP?

BSI MODEL TIP is a medical device that received FDA 510(k) clearance on 1990-07-13. The listed applicant is Bales Scientific, Inc.. The 510(k) number is K897191.

When did BSI MODEL TIP receive FDA 510(k) clearance?

BSI MODEL TIP received FDA 510(k) clearance on 1990-07-13, under 510(k) number K897191.

Who is the listed applicant for BSI MODEL TIP?

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

What is the FDA product code for BSI MODEL TIP?

The FDA product code for BSI MODEL TIP is LHQ.

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Other records listing Bales Scientific, Inc. 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.

K974468PHOTONIC STIMULATORK850534BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM

Related Devices (Code: LHQ)

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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