FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLD CD ASP MODULE, ITE
K Number: K933041
·
Decision Aug 2, 1993
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
29
Applicant Total
73
Review Days
96
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Basic Information
- Device Name
- COLD CD ASP MODULE, ITE
- K Number
- K933041
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Electone, Inc.
- Date Received
- April 28, 1993
- Decision Date
- August 2, 1993
- Product Code
- LRS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRS | I.V. Start Kit | FDA class 2 | General Hospital |
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Other Clearances by Electone, Inc.
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|---|---|---|---|
| K973266 | Z DEQ-II | Sep 23, 1997 | Substantially Equivalent |
| K961084 | AM 400 | Apr 18, 1996 | Substantially Equivalent |
| K955702 | SONATA U-01 | Feb 22, 1996 | Substantially Equivalent |
| K953050 | Z33 | Aug 22, 1995 | Substantially Equivalent |
| K953047 | Z20 | Aug 22, 1995 | Substantially Equivalent |
| K953053 | AM 260 PP | Aug 15, 1995 | Substantially Equivalent |
| K953052 | AM 260 K-AMP | Aug 15, 1995 | Substantially Equivalent |
| K953054 | AM 260 OHM | Aug 15, 1995 | Substantially Equivalent |
| K953051 | Z35 | Aug 15, 1995 | Substantially Equivalent |
| K953048 | Z22 | Aug 15, 1995 | Substantially Equivalent |