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FDA 510(k)

LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED

K-Number: K905522 · 1991-06-11

ApplicantLaboratory Equipment Corp.
Decision Date1991-06-11
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Laboratory Equipment Corp.. It received FDA 510(k) clearance on 1991-06-11 under 510(k) number K905522. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED?

LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED is a medical device that received FDA 510(k) clearance on 1991-06-11. The listed applicant is Laboratory Equipment Corp.. The 510(k) number is K905522.

When did LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED receive FDA 510(k) clearance?

LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED received FDA 510(k) clearance on 1991-06-11, under 510(k) number K905522.

Who is the listed applicant for LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED?

The FDA 510(k) record lists Laboratory Equipment Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED?

The FDA product code for LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED is IYO.

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 Laboratory Equipment Corp. 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.

K890519LABSONICS MAMM-O-MATE MODEL NO. 918084-1

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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