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FDA 510(k)

TEC 2101 (MODEL MT-HPLGD)

K-Number: K941169 · 1994-07-18

ApplicantMedtec, Inc.
Decision Date1994-07-18
Product CodeIWE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TEC 2101 (MODEL MT-HPLGD) is the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc.. It received FDA 510(k) clearance on 1994-07-18 under 510(k) number K941169. The device is classified under product code IWE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEC 2101 (MODEL MT-HPLGD)?

TEC 2101 (MODEL MT-HPLGD) is a medical device that received FDA 510(k) clearance on 1994-07-18. The listed applicant is Medtec, Inc.. The 510(k) number is K941169.

When did TEC 2101 (MODEL MT-HPLGD) receive FDA 510(k) clearance?

TEC 2101 (MODEL MT-HPLGD) received FDA 510(k) clearance on 1994-07-18, under 510(k) number K941169.

Who is the listed applicant for TEC 2101 (MODEL MT-HPLGD)?

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

What is the FDA product code for TEC 2101 (MODEL MT-HPLGD)?

The FDA product code for TEC 2101 (MODEL MT-HPLGD) is IWE.

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Other records listing Medtec, 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.

K111340HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEMK093738MRI PATIENT POSITIONING DEVICESK974703CARBON FIBER BREAST BOARDK974700MATRIX MT-MX3K973842CARBON FIBER CONFORMAL COUCH TOPK962622INTRA-ORAL THERMOPLASTIC SHIELD

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Related Devices (Code: IWE)

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.

K973162DUAL RADIATION TARGETING SYSTEM DRTS DRAPEHogan & HartsonK955236GREEN TEC-2100Medtec, Inc.K954414CENTRALITE BACKPOINTERDiacor, Inc.K950293TEC-2110 GREEN LASER MODEL MT-HNGMedtec, Inc.K950112CENTRALITE(R)-DLL SERIESDiacor, Inc.K951601MED-TEC STRING RETICLE TRAYMedtec, 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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