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FDA 510(k)

THE SPANTRON FRAME FREEZE

K-Number: K890477 · 1989-03-31

ApplicantSpantron, Inc.
Decision Date1989-03-31
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE SPANTRON FRAME FREEZE is the device name listed in this FDA 510(k) record. The listed applicant is Spantron, Inc.. It received FDA 510(k) clearance on 1989-03-31 under 510(k) number K890477. The device is classified under product code LMA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE SPANTRON FRAME FREEZE?

THE SPANTRON FRAME FREEZE is a medical device that received FDA 510(k) clearance on 1989-03-31. The listed applicant is Spantron, Inc.. The 510(k) number is K890477.

When did THE SPANTRON FRAME FREEZE receive FDA 510(k) clearance?

THE SPANTRON FRAME FREEZE received FDA 510(k) clearance on 1989-03-31, under 510(k) number K890477.

Who is the listed applicant for THE SPANTRON FRAME FREEZE?

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

What is the FDA product code for THE SPANTRON FRAME FREEZE?

The FDA product code for THE SPANTRON FRAME FREEZE is LMA.

Related Clinical Trials

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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Other records listing Spantron, 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.

K895546MODIFIED SPANTRON FRAME FREEZE

Related Devices (Code: LMA)

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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