FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONARK 869 ERGOMETER
K Number: K855102
·
Decision May 9, 1986
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
161
Applicant Total
7
Review Days
137
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Basic Information
- Device Name
- MONARK 869 ERGOMETER
- K Number
- K855102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3535
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Equilibrated Bio Systems, Inc.
- Date Received
- December 23, 1985
- Decision Date
- May 9, 1986
- Product Code
- DSP
- 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 |
|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | FDA class 2 | Cardiovascular |
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Other Clearances by Equilibrated Bio Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892705 | EBS2605 INFANT HUGGER | Oct 27, 1989 | Substantially Equivalent |
| K843996 | TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER | Nov 20, 1984 | Substantially Equivalent |
| K791294 | SPIROCAL | Aug 16, 1979 | Substantially Equivalent |
| K790410 | ADULT ZEE-FRAME | Mar 22, 1979 | Substantially Equivalent |
| K781509 | ZEE-FRAME | Sep 26, 1978 | Substantially Equivalent |
| K781386 | EBS 775 TONOMETER | Sep 14, 1978 | Substantially Equivalent |