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FDA 510(k)

Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)

K-Number: K241318 · 2024-08-30

ApplicantAdaptiiv Medical Technologies, Inc.
Decision Date2024-08-30
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) is a medical device manufactured by Adaptiiv Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-08-30 under approval number K241318. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)?

Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) is a medical device that received FDA 510(k) clearance on 2024-08-30. It is manufactured by Adaptiiv Medical Technologies, Inc.. The 510(k) number is K241318.

When was Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) approved by the FDA?

Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) received FDA 510(k) clearance on 2024-08-30, under approval number K241318.

What company makes Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)?

Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) is manufactured by Adaptiiv Medical Technologies, Inc..

What is the FDA product code for Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)?

The FDA product code for Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) is MUJ.

Other Devices by Adaptiiv Medical Technologies, Inc.

K243057TrueFit Bolus; TrueFlex Bolus K260308TrueFit Bolus

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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.

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