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FDA 510(k)

HEPCON HMS WITH BODY SURFACE AREA CALCULATION

K-Number: K911240 · 1991-07-17

ApplicantHemotech, Inc.
Decision Date1991-07-17
Product CodeJOX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEPCON HMS WITH BODY SURFACE AREA CALCULATION is the device name listed in this FDA 510(k) record. The listed applicant is Hemotech, Inc.. It received FDA 510(k) clearance on 1991-07-17 under 510(k) number K911240. The device is classified under product code JOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEPCON HMS WITH BODY SURFACE AREA CALCULATION?

HEPCON HMS WITH BODY SURFACE AREA CALCULATION is a medical device that received FDA 510(k) clearance on 1991-07-17. The listed applicant is Hemotech, Inc.. The 510(k) number is K911240.

When did HEPCON HMS WITH BODY SURFACE AREA CALCULATION receive FDA 510(k) clearance?

HEPCON HMS WITH BODY SURFACE AREA CALCULATION received FDA 510(k) clearance on 1991-07-17, under 510(k) number K911240.

Who is the listed applicant for HEPCON HMS WITH BODY SURFACE AREA CALCULATION?

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

What is the FDA product code for HEPCON HMS WITH BODY SURFACE AREA CALCULATION?

The FDA product code for HEPCON HMS WITH BODY SURFACE AREA CALCULATION is JOX.

Related Clinical Trials

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.

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Related Devices (Code: JOX)

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.

K111339HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)Medtronic, Inc.K102953HEPARIN DOSE RESPONSE CARTRIDGEMedtronic, Inc.K101271HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XXMedtronic, Inc.K051040HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 PORMedtronic Perfusion SystemsK043080HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 PORMedtronic VascularK042070HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20Medtronic Vascular

Official Source

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