FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEVETHERM
K Number: K822873
·
Decision Mar 24, 1983
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
2
Review Days
178
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Basic Information
- Device Name
- DEVETHERM
- K Number
- K822873
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2750
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Eko Scann AB
- Date Received
- September 27, 1982
- Decision Date
- March 24, 1983
- Product Code
- DQB
- 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 |
|---|---|---|---|
| DQB | Phlebograph, Impedance | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQB), ordered by most recent decision date.
VASOSCREEN IMPEDANCE PLETHYSMOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
IMPEDANCE RHEOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Eko Scann AB
| K Number | Device Name | ||
|---|---|---|---|
| K822823 | HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT | Oct 18, 1982 | Substantially Equivalent |