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FDA 510(k)

GREEN TEC-2100

K-Number: K955236 · 1996-05-24

ApplicantMedtec, Inc.
Decision Date1996-05-24
Product CodeIWE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GREEN TEC-2100 is the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc.. It received FDA 510(k) clearance on 1996-05-24 under 510(k) number K955236. 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 GREEN TEC-2100?

GREEN TEC-2100 is a medical device that received FDA 510(k) clearance on 1996-05-24. The listed applicant is Medtec, Inc.. The 510(k) number is K955236.

When did GREEN TEC-2100 receive FDA 510(k) clearance?

GREEN TEC-2100 received FDA 510(k) clearance on 1996-05-24, under 510(k) number K955236.

Who is the listed applicant for GREEN TEC-2100?

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 GREEN TEC-2100?

The FDA product code for GREEN TEC-2100 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 & HartsonK954414CENTRALITE BACKPOINTERDiacor, Inc.K950293TEC-2110 GREEN LASER MODEL MT-HNGMedtec, Inc.K950112CENTRALITE(R)-DLL SERIESDiacor, Inc.K951601MED-TEC STRING RETICLE TRAYMedtec, Inc.K943802HP BACK POINTER SYSTEMMedtec, 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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