FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SERIES 1800 EXERCISE TREADMILL
K Number: K802836
·
Decision Dec 11, 1980
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
42
Applicant Total
82
Review Days
29
Basic Information
- Device Name
- SERIES 1800 EXERCISE TREADMILL
- K Number
- K802836
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- MARQUETTE ELECTRONICS, INC.
- Date Received
- November 12, 1980
- Decision Date
- December 11, 1980
- Product Code
- IOL
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IOL | Treadmill, Powered | FDA class 1 | Physical Medicine |
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| K962827 | ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) | Feb 24, 1997 | Substantially Equivalent |
| K964750 | EAGLE 4000 PATIENT MONITOR | Feb 21, 1997 | Substantially Equivalent |
| K962551 | CARDIOSERV S | Nov 19, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K960418 | EAGLE PATIENT MONITOR | Oct 2, 1996 | Substantially Equivalent |
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