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FDA 510(k)

RESPA-TROL

K-Number: K810107 · 1981-01-26

ApplicantIntensive Technology, Inc.
Decision Date1981-01-26
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RESPA-TROL is the device name listed in this FDA 510(k) record. The listed applicant is Intensive Technology, Inc.. It received FDA 510(k) clearance on 1981-01-26 under 510(k) number K810107. The device is classified under product code JJS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPA-TROL?

RESPA-TROL is a medical device that received FDA 510(k) clearance on 1981-01-26. The listed applicant is Intensive Technology, Inc.. The 510(k) number is K810107.

When did RESPA-TROL receive FDA 510(k) clearance?

RESPA-TROL received FDA 510(k) clearance on 1981-01-26, under 510(k) number K810107.

Who is the listed applicant for RESPA-TROL?

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

What is the FDA product code for RESPA-TROL?

The FDA product code for RESPA-TROL is JJS.

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Other records listing Intensive Technology, 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.

K922970INTRA-OPERATIVE TEC ATHERECTOMY SYSTEMK912664TEC ROTATING DUAL HEMOVALVEK911869IVT GUIDING CATHETERK903463IVT INTRODUCER SHEATHK904003HEMOCHRON(R) HEPARIN RESPONSE TESTK901767MODIFIED IVT PERIPHERAL ATHERECTOMY

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Related Devices (Code: JJS)

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.

K152553CueSee HypoxicEurotrol B.V.K130415HIGH METABOLITE QUALICHECKRadiometer Medical ApsK130236RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3Radiometer Medical ApsK033063MISSION CONTROLSDiamond Diagnostics, Inc.K022525LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509Bio-RadK022529LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669Bio-Rad

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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