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FDA 510(k)

BLA-800A

K-Number: K954310 · 1995-10-18

ApplicantToshiba Medical Systems
Decision Date1995-10-18
Product CodeKPW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BLA-800A is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems. It received FDA 510(k) clearance on 1995-10-18 under 510(k) number K954310. The device is classified under product code KPW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLA-800A?

BLA-800A is a medical device that received FDA 510(k) clearance on 1995-10-18. The listed applicant is Toshiba Medical Systems. The 510(k) number is K954310.

When did BLA-800A receive FDA 510(k) clearance?

BLA-800A received FDA 510(k) clearance on 1995-10-18, under 510(k) number K954310.

Who is the listed applicant for BLA-800A?

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

What is the FDA product code for BLA-800A?

The FDA product code for BLA-800A is KPW.

Other records listing Toshiba Medical Systems 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.

K960948SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020AK954309ANGIOREXK893750MRT-50A MOBILEK891453DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582VK890969TRANSESOPHAGEAL TRANSDUCER PEF-511SAK884555TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM

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Related Devices (Code: KPW)

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.

K093596LUMOS, MODEL R 72BLumos, Inc.K062788COLLIMATOR, MODEL M-38Umi InternationalK030487R 72Ralco S.R.L.K946320R 302Ralco S.R.L.K914184P2020-8-0 BEAM-LIMITING DEVICEPrecise OpticsK904587DENSICOMP 250L. Keroack Co.

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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