FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIO-SLIDECOMP
K Number: K790869
·
Decision May 17, 1979
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
570
Applicant Total
1
Review Days
10
Basic Information
- Device Name
- CARDIO-SLIDECOMP
- K Number
- K790869
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- CREATIVE INSTRUMENTS
- Date Received
- May 7, 1979
- Decision Date
- May 17, 1979
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPS), ordered by most recent decision date.
ZBPro Diagnostic
FDA 510(k)
FDA Class 2
·Cardiovascular
Masimo W1
FDA 510(k)
FDA Class 2
·Cardiovascular
CloudHRV System (100-01-001)
FDA 510(k)
FDA Class 2
·Cardiovascular
Cardiac Workstation (5000); Cardiac Workstation (7000)
FDA 510(k)
FDA Class 2
·Cardiovascular
Masimo W1
FDA 510(k)
FDA Class 2
·Cardiovascular
DeepRhythm Platform
FDA 510(k)
FDA Class 2
·Cardiovascular