FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Tempus LS - Manual
K Number: K200849
·
Decision Jul 24, 2020
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
1
Review Days
115
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Basic Information
- Device Name
- Tempus LS - Manual
- K Number
- K200849
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Remote Diagnostic Technologies, Ltd. A Philips Company
- Date Received
- March 31, 2020
- Decision Date
- July 24, 2020
- Product Code
- LDD
- 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 |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | FDA class 2 | Cardiovascular |
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