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510(k) K181929

MiMo(TM) Negative Pressure Wound Therapy System by Baymax Research, Inc. — Product Code OMP

K181929 is an FDA 510(k) premarket notification submitted by Baymax Research, Inc. for the device "MiMo(TM) Negative Pressure Wound Therapy System". The FDA issued a decision of Substantially Equivalent on Mar 27, 2019. The device falls under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump), a Class II device regulated under 21 CFR 878.4780.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 27, 2019
Date Received
Jul 18, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type
510(k)

For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

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FDA data resources