FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYBEX 770
K Number: K950095
·
Decision Jun 21, 1995
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
60
Applicant Total
9
Review Days
162
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Basic Information
- Device Name
- CYBEX 770
- K Number
- K950095
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1925
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cybex
- Date Received
- January 10, 1995
- Decision Date
- June 21, 1995
- Product Code
- IKK
- 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 |
|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | FDA class 2 | Physical Medicine |
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Other Clearances by Cybex
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K894154 | METABOLIC SYSTEMS | Oct 24, 1989 | 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 |