Mc10, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
1
Total
1
Cleared
0
Denied
Mc10, Inc. is a medical device company with a manufacturing facility in Lexington, Massachusetts. The company specializes in wearable sensor technology for clinical applications.
Mc10 has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory focus is Cardiovascular devices. The BioStamp nPoint represents the company's cleared product in this category. Mc10's FDA 510(k) clearance was granted in 2018.
Mc10 is currently inactive in FDA submissions, with no clearances recorded in the past five years. This profile serves as a historical regulatory record for the company's prior device development activities.
510(k) submissions have been managed by Hogan Lovells as regulatory consultant.
FDA 510(k) Regulatory Record - Mc10, Inc.
1 devices