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FDA 510(k)

MODEL 1859 TUMI/PRESSURE MODULE

K-Number: K873695 · 1988-01-27

ApplicantLife-Tech Intl., Inc.
Decision Date1988-01-27
Product CodeEXY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODEL 1859 TUMI/PRESSURE MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Intl., Inc.. It received FDA 510(k) clearance on 1988-01-27 under 510(k) number K873695. The device is classified under product code EXY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 1859 TUMI/PRESSURE MODULE?

MODEL 1859 TUMI/PRESSURE MODULE is a medical device that received FDA 510(k) clearance on 1988-01-27. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K873695.

When did MODEL 1859 TUMI/PRESSURE MODULE receive FDA 510(k) clearance?

MODEL 1859 TUMI/PRESSURE MODULE received FDA 510(k) clearance on 1988-01-27, under 510(k) number K873695.

Who is the listed applicant for MODEL 1859 TUMI/PRESSURE MODULE?

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

What is the FDA product code for MODEL 1859 TUMI/PRESSURE MODULE?

The FDA product code for MODEL 1859 TUMI/PRESSURE MODULE is EXY.

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Other records listing Life-Tech Intl., 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.

K001129PROLONG, MODELS PL50, PL100, PL150K955031MAXISTIMK954505EZ STIMK954315PVC ABDOMINAL/RECTAL PRESSURE CATHETERK954341URODYNAMICS TUBING AND INFUSION SETSK953451UROPUMP TUBE & DAMPING CHAMGER

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Related Devices (Code: EXY)

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.

K022721UROPOWERW.O.M. World of Medicine AGK971913GR100F URINE FLOWMETERAlbyn Medical , Ltd.K953999DANTEC DA CAPODantec Medical, Inc.K951442FLOLABSynectics Medical, Inc.K944972URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRYMyo/Kinetic Systems, Inc.K9454954-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTIONFiberoptic Sensor Technlogies, 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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