FDA 510(k)

TED 191

K-Number: K963177 · 1997-11-13

Decision Date1997-11-13

Product CodeCCL

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TED 191 is the device name listed in this FDA 510(k) record. The listed applicant is Teledyne Brown Engineering. It received FDA 510(k) clearance on 1997-11-13 under 510(k) number K963177. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TED 191?

TED 191 is a medical device that received FDA 510(k) clearance on 1997-11-13. The listed applicant is Teledyne Brown Engineering. The 510(k) number is K963177.

When did TED 191 receive FDA 510(k) clearance?

TED 191 received FDA 510(k) clearance on 1997-11-13, under 510(k) number K963177.

Who is the listed applicant for TED 191?

The FDA 510(k) record lists Teledyne Brown Engineering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TED 191?

The FDA product code for TED 191 is CCL.

Other records listing Teledyne Brown Engineering 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.

K953905IMPERIUM

Related Devices (Code: CCL)

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs K251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLC K221734Maxtec MaxO2 ME+pMaxtec, LLC K213933Percent Oxygen SensorsCareox, LLC K213948OxyMinderBio-Med Devices, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.