FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZOLL Propaq M
K Number: K202375
·
Decision Mar 9, 2021
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
30
Review Days
201
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Basic Information
- Device Name
- ZOLL Propaq M
- K Number
- K202375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ZOLL Medical Corporation
- Date Received
- August 20, 2020
- Decision Date
- March 9, 2021
- 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 ZOLL Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K233486 | 731 Series Ventilator | Dec 13, 2024 | Substantially Equivalent |
| K180482 | ZOLL Propaq M | Nov 30, 2018 | Substantially Equivalent |
| K172653 | Power Infuser | Jul 18, 2018 | Substantially Equivalent |
| 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 |
| K131919 | ZOLL EPCR IOS | Dec 17, 2013 | Substantially Equivalent |