FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DAISCOPE & ACCESSORIES
K Number: K790506
·
Decision Apr 9, 1979
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
2
Review Days
27
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Basic Information
- Device Name
- DAISCOPE & ACCESSORIES
- K Number
- K790506
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Simonsen & Weels Eftf.
- Date Received
- March 13, 1979
- Decision Date
- April 9, 1979
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by Simonsen & Weels Eftf.
| K Number | Device Name | ||
|---|---|---|---|
| K790507 | 800 ECG ELECTRODE | May 18, 1979 | Substantially Equivalent |