FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SUN-LITE BLUE SPOT
K Number: K840427
·
Decision May 9, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
31
Review Days
99
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SUN-LITE BLUE SPOT
- K Number
- K840427
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Suncoast Medical Manufacturers, Inc.
- Date Received
- January 31, 1984
- Decision Date
- May 9, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- OP
- Third Party
- N
Other Clearances by Suncoast Medical Manufacturers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841604 | ADJUST-A-TEMP HIGH TEMPERATURE | Dec 7, 1984 | Substantially Equivalent |
| K841459 | REPLACE-A-TIP ADJUST. LOW TEMP.- | Dec 7, 1984 | Substantially Equivalent |
| K841509 | REPLACE-A-TIP ADJUSTABLE HIGH TEMP. | Dec 7, 1984 | Substantially Equivalent |
| K841603 | ADJUST-A-TEMP MICRO | Dec 7, 1984 | Substantially Equivalent |
| K841591 | PYRO-TIP | Oct 31, 1984 | Substantially Equivalent |
| K840376 | SURG-A STAT LOOP TIP | Oct 26, 1984 | Substantially Equivalent |
| K840375 | SURG-A-STAT LOOP TIP 15 | Jul 23, 1984 | Substantially Equivalent |
| K840387 | SURG-A-STAT LOOP TIP 2 | Jul 23, 1984 | Substantially Equivalent |
| K840370 | SURG-A-STAT VASECTOMY TIP | Jul 23, 1984 | Substantially Equivalent |
| K840377 | SURG-A-STAT CARDIOVASCULAR TIP | Jul 23, 1984 | Substantially Equivalent |