FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNICET I
K Number: K770529
·
Decision Apr 5, 1977
Classifications
1
FEI Numbers
171
Registration Numbers
171
Same Product Code
8
Applicant Total
69
Review Days
15
Basic Information
- Device Name
- UNICET I
- K Number
- K770529
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3075
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- UNION CARBIDE CORP.
- Date Received
- March 21, 1977
- Decision Date
- April 5, 1977
- Product Code
- IPS
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IPS | Cane | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IPS), ordered by most recent decision date.
CANE REACHER
FDA 510(k)
FDA Class 1
·Physical Medicine
WALKING CANE
FDA 510(k)
FDA Class 1
·Physical Medicine
LIGHT WEIGHT ALUMINUM CANES
FDA 510(k)
FDA Class 1
·Physical Medicine
OFFSET ALUMINUM CANE
FDA 510(k)
FDA Class 1
·Physical Medicine
CERSA-CANE
FDA 510(k)
FDA Class 1
·Physical Medicine
FOREARM-CANE
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by UNION CARBIDE CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K830337 | MARK III OXYGEN WALKER SYS-LOW PRESS | Mar 17, 1983 | Substantially Equivalent |
| K820836 | MARK III OXYGEN WALKER SYSTEM | Apr 15, 1982 | Substantially Equivalent |
| K820535 | LASER GAS MIXTURES | Mar 31, 1982 | Substantially Equivalent |
| K812536 | LINDE MARK II | Sep 23, 1981 | Substantially Equivalent |
| K810732 | LINDE MARK II OXYGEN RESERV. TYPE OR-4 | Mar 27, 1981 | Substantially Equivalent |
| K810596 | CENTRIFI CHEM SYSTEM 400 ANALYZER | Mar 17, 1981 | Substantially Equivalent |
| K810129 | CENTRIFICHEM SYSTEM 500 | Feb 2, 1981 | Substantially Equivalent |
| K803216 | CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT | Jan 9, 1981 | Substantially Equivalent |
| K802741 | CENTRIFICHEM COMB. SERUM-BASED CALIB. | Dec 10, 1980 | Substantially Equivalent |
| K802520 | CENTRIFICHEM PIPETTOR ACCURACY CALIB. | Nov 12, 1980 | Substantially Equivalent |