FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO DATACAPTOR
K Number: K020197
·
Decision Feb 21, 2002
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
5
Review Days
30
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Basic Information
- Device Name
- MODIFICATION TO DATACAPTOR
- K Number
- K020197
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Capsule Technologie
- Date Received
- January 22, 2002
- Decision Date
- February 21, 2002
- Product Code
- MWI
- 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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Capsule Technologie
| K Number | Device Name | ||
|---|---|---|---|
| K183638 | SmartLinx Vitals Plus Patient Monitoring System | Apr 17, 2019 | Substantially Equivalent |
| K180734 | SmartLinx Vitals Plus Patient Monitoring System | Aug 8, 2018 | Substantially Equivalent |
| K032142 | DATACAPTOR | Aug 8, 2003 | Substantially Equivalent |
| K013019 | DATACAPTOR | Dec 18, 2001 | Substantially Equivalent |