FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
NT1D VITAL SIGNS MONITOR
K Number: K123797
·
Decision Aug 27, 2013
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
1
Review Days
260
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Basic Information
- Device Name
- NT1D VITAL SIGNS MONITOR
- K Number
- K123797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- New Tech, Inc.
- Date Received
- December 10, 2012
- Decision Date
- August 27, 2013
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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