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FDA 510(k)

InkSpace Imaging Pediatric Body Array

K-Number: K213397 · 2021-12-17

ApplicantInkspace Imaging, Inc.
Decision Date2021-12-17
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

InkSpace Imaging Pediatric Body Array is the device name listed in this FDA 510(k) record. The listed applicant is Inkspace Imaging, Inc.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K213397. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InkSpace Imaging Pediatric Body Array?

InkSpace Imaging Pediatric Body Array is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Inkspace Imaging, Inc.. The 510(k) number is K213397.

When did InkSpace Imaging Pediatric Body Array receive FDA 510(k) clearance?

InkSpace Imaging Pediatric Body Array received FDA 510(k) clearance on 2021-12-17, under 510(k) number K213397.

Who is the listed applicant for InkSpace Imaging Pediatric Body Array?

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

What is the FDA product code for InkSpace Imaging Pediatric Body Array?

The FDA product code for InkSpace Imaging Pediatric Body Array is MOS.

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.

NCT07488429Impact of rTMS Combined With Neurorehabilitation on Lower Extremity Motor Function and Spasticity in Children With Spastic Diplegic Cerebral PalsyRECRUITING

Other records listing Inkspace Imaging, 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.

K253182InkSpace Imaging Small Body Array (SBA12PH30x)K243675InkSpace Imaging Small Body ArrayK233444InkSpace Imaging Small Body ArrayK223487InkSpace Imaging Body Array

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Official Source

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