FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TA620 TREADMILL CONTROLLER
K Number: K913518
·
Decision Oct 24, 1991
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
7
Review Days
78
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Basic Information
- Device Name
- TA620 TREADMILL CONTROLLER
- K Number
- K913518
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Siemens Burdick, Inc.
- Date Received
- August 7, 1991
- Decision Date
- October 24, 1991
- 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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Other Clearances by Siemens Burdick, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K915327 | ELITE II ELECTROCARDIOGRAPH,MODIFIED | Oct 9, 1992 | Substantially Equivalent |
| K915225 | MEGACART | Jul 1, 1992 | Substantially Equivalent |
| K915202 | INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPH | May 15, 1992 | Substantially Equivalent |
| K914969 | E350I ELECTROCARDIOGRAPH | Mar 26, 1992 | Substantially Equivalent |
| K910634 | DC200 DEFIBRILLATOR | Jul 24, 1991 | Substantially Equivalent |
| K910867 | T600 TREADMILL | May 31, 1991 | Substantially Equivalent |