FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR
K Number: K944688
·
Decision Nov 1, 1994
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
25
Applicant Total
7
Review Days
40
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Basic Information
- Device Name
- LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR
- K Number
- K944688
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Progressive Dynamics, Inc.
- Date Received
- September 22, 1994
- Decision Date
- November 1, 1994
- Product Code
- FFS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FFS | Image, Illumination, Fiberoptic, For Endoscope | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Progressive Dynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952329 | LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM | Jan 17, 1996 | Substantially Equivalent |
| K933764 | LIFE-AIR 1000 PATIENT WARMING COVER | Nov 9, 1993 | Substantially Equivalent |
| K933593 | LUMINOUS 150 FIBEROPTIC ILLUMINATOR | Oct 28, 1993 | Substantially Equivalent |
| K921866 | LUMINOUS 250 FIBEROPTIC ILLUMINATOR | Jul 8, 1992 | Substantially Equivalent |
| K914382 | LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM | Apr 21, 1992 | Substantially Equivalent |
| K914383 | LIFE-AIR 1000 PATIENT WARMING COVERS | Mar 30, 1992 | Substantially Equivalent |