Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TEC 1410

K-Number: K904397 · 1990-11-13

ApplicantBay Shore Medical Equipment Corp.
Decision Date1990-11-13
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TEC 1410 is the device name listed in this FDA 510(k) record. The listed applicant is Bay Shore Medical Equipment Corp.. It received FDA 510(k) clearance on 1990-11-13 under 510(k) number K904397. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEC 1410?

TEC 1410 is a medical device that received FDA 510(k) clearance on 1990-11-13. The listed applicant is Bay Shore Medical Equipment Corp.. The 510(k) number is K904397.

When did TEC 1410 receive FDA 510(k) clearance?

TEC 1410 received FDA 510(k) clearance on 1990-11-13, under 510(k) number K904397.

Who is the listed applicant for TEC 1410?

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

What is the FDA product code for TEC 1410?

The FDA product code for TEC 1410 is IZO.

Other records listing Bay Shore Medical 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.

K922814TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICATK892342TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM

Related Devices (Code: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, 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.

↑