FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PCA-C1 series Patient Cable
K Number: K200722
·
Decision Jun 3, 2021
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
104
Applicant Total
4
Review Days
441
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Basic Information
- Device Name
- PCA-C1 series Patient Cable
- K Number
- K200722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- QT Medical, Inc.
- Date Received
- March 19, 2020
- Decision Date
- June 3, 2021
- Product Code
- DSA
- 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 |
|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | FDA class 2 | Cardiovascular |
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