FDA 510(k)

DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100

K-Number: K071399 · 2007-06-20

Decision Date2007-06-20

Product CodeLHN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 is the device name listed in this FDA 510(k) record. The listed applicant is Sicel Technologies, Inc.. It received FDA 510(k) clearance on 2007-06-20 under 510(k) number K071399. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100?

DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 is a medical device that received FDA 510(k) clearance on 2007-06-20. The listed applicant is Sicel Technologies, Inc.. The 510(k) number is K071399.

When did DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 receive FDA 510(k) clearance?

DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 received FDA 510(k) clearance on 2007-06-20, under 510(k) number K071399.

Who is the listed applicant for DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100?

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

What is the FDA product code for DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100?

The FDA product code for DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 is LHN.

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Other records listing Sicel Technologies, Inc. as applicant

K083035DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM K081859MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM K080004DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM K061051DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER K052118DOSE VERIFICATION SYSTEM K040687ONEDOSE PATIENT DOSIMETRY SYSTEM

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Related Devices (Code: LHN)

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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.