FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ULTRASCAN DIGITAL A/SYSTEM III
K Number: K828328
·
Decision Mar 3, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
54
Review Days
78
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Basic Information
- Device Name
- ULTRASCAN DIGITAL A/SYSTEM III
- K Number
- K828328
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Cooper Lasersonics, Inc.
- Date Received
- December 15, 1982
- Decision Date
- March 3, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
Other Clearances by Cooper Lasersonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880429 | ILLUMINA 55 CO2 LASER SYSTEM | Apr 18, 1988 | Substantially Equivalent |
| K880427 | ILLUMINA 40 CO2 LASER SYSTEM | Apr 18, 1988 | Substantially Equivalent |
| K880807 | ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU | Apr 18, 1988 | Substantially Equivalent |
| K880428 | ILLUMINA 25 CO2 LASER SYSTEM | Apr 18, 1988 | Substantially Equivalent |
| K880808 | ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU | Apr 18, 1988 | Substantially Equivalent |
| K880809 | ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU | Apr 18, 1988 | Substantially Equivalent |
| K880171 | MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL | Apr 11, 1988 | Substantially Equivalent |
| K880170 | MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | Mar 24, 1988 | Substantially Equivalent |
| K880173 | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION | Mar 24, 1988 | Substantially Equivalent |
| K880172 | MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. | Mar 11, 1988 | Substantially Equivalent |