FDA 510(k)
Substantially Equivalent
🇺🇸 United States
AMBULASE XAM-15 XANAR SURG. LASER
K Number: K833325
·
Decision Jan 26, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
12
Review Days
121
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Basic Information
- Device Name
- AMBULASE XAM-15 XANAR SURG. LASER
- K Number
- K833325
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Xanar, Inc.
- Date Received
- September 27, 1983
- Decision Date
- January 26, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Xanar, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861688 | XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15 | Oct 3, 1986 | Substantially Equivalent |
| K852436 | AMBULASE | Apr 18, 1986 | Substantially Equivalent |
| K860496 | MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY | Mar 14, 1986 | Substantially Equivalent |
| K853620 | MODEL XA-50 - CO2 SURGICAL LASER | Jan 24, 1986 | Substantially Equivalent |
| K850818 | CO 2 SURGICAL LASER SYSTEM NA-120 | Aug 15, 1985 | Substantially Equivalent |
| K850804 | CO 2 SURGICAL LASER SYSTEM NA-30 | Aug 15, 1985 | Substantially Equivalent |
| K850805 | CO 2 SURGICAL LASER SYSTEM MODEL NA-40 | Aug 15, 1985 | Substantially Equivalent |
| K844087 | XANAR MODEL XSE-300 SMOKE EVACULATER | Feb 27, 1985 | Substantially Equivalent |
| K841860 | CO2 SURGICAL LASER SYSTEM XML-10 | Nov 8, 1984 | Substantially Equivalent |
| K837224 | UNKNOWN | May 2, 1983 | Substantially Equivalent |