FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZOLL R SERIES
K Number: K081574
·
Decision Sep 18, 2008
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
30
Review Days
105
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Basic Information
- Device Name
- ZOLL R SERIES
- K Number
- K081574
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ZOLL Medical Corporation
- Date Received
- June 5, 2008
- Decision Date
- September 18, 2008
- 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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| K162832 | 731 Series Ventilators | Aug 2, 2017 | Substantially Equivalent |
| K170533 | Model 330 Multifunction Aspirator | Apr 18, 2017 | Substantially Equivalent |
| K142915 | ZOLL X Series | Dec 3, 2014 | Substantially Equivalent |
| K141774 | ZOLL X SERIES | Nov 19, 2014 | Substantially Equivalent |
| K140502 | ZOLL E SERIES ALS | Nov 6, 2014 | Substantially Equivalent |
| K132488 | ZOLL CODE WRITER | Apr 3, 2014 | Substantially Equivalent |