FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
METABOLIC SYSTEMS
K Number: K894154
·
Decision Oct 24, 1989
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
60
Applicant Total
9
Review Days
132
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Basic Information
- Device Name
- METABOLIC SYSTEMS
- K Number
- K894154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5360
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Cybex
- Date Received
- June 14, 1989
- Decision Date
- October 24, 1989
- Product Code
- ISD
- 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 |
|---|---|---|---|
| ISD | Exerciser, Measuring | FDA class 2 | Physical Medicine |
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Other Clearances by Cybex
| K Number | Device Name | ||
|---|---|---|---|
| K950095 | CYBEX 770 | Jun 21, 1995 | Substantially Equivalent |
| K905525 | CYBEX 6000 | Feb 14, 1991 | Substantially Equivalent |
| K881676 | LINEAR LIFT DEVICE | Apr 25, 1990 | Substantially Equivalent |
| K881681 | CYBEX BACK TESTING AND REHABILITATION SYSTEM | Apr 25, 1990 | Substantially Equivalent |
| K873599 | EDI 320 | Oct 16, 1987 | Substantially Equivalent |
| K872911 | CYBEX 340 | Sep 24, 1987 | Substantially Equivalent |
| K844368 | LINEAR LIFT DEVICE | Feb 19, 1985 | Substantially Equivalent |
| K843739 | CYBEX TORSO TESTING & REHABILITATION | Nov 29, 1984 | Substantially Equivalent |