FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
K Number: K190073
·
Decision Mar 27, 2019
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
116
Applicant Total
4
Review Days
70
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Basic Information
- Device Name
- Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
- K Number
- K190073
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Current Health , Ltd.
- Date Received
- January 16, 2019
- Decision Date
- March 27, 2019
- Product Code
- MSX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | FDA class 2 | Cardiovascular |
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