FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A
K Number: K801866
·
Decision Sep 16, 1980
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
7
Applicant Total
67
Review Days
42
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Basic Information
- Device Name
- PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A
- K Number
- K801866
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4750
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Pentax Precision Instrument Corp.
- Date Received
- August 5, 1980
- Decision Date
- September 16, 1980
- Product Code
- EQL
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EQL | Laryngostroboscope | FDA class 1 | Ear, Nose, Throat |
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FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
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FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Pentax Precision Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K041396 | FG-36UX FIBER ULTRASOUND GASTROSCOPE | Jun 9, 2004 | Substantially Equivalent |
| K041395 | EG-3630UR | Jun 9, 2004 | Substantially Equivalent |
| K041397 | EG-3830UT | Jun 9, 2004 | Substantially Equivalent |
| K031789 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | Aug 8, 2003 | Substantially Equivalent |
| K023401 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | Feb 11, 2003 | Substantially Equivalent |
| K023376 | EB-1830T3, VIDEO BRONCHOSCOPE | Oct 16, 2002 | Substantially Equivalent |
| K021276 | FG-36UX FIBER ULTRASOUND GASTROSCOPE | Sep 12, 2002 | Substantially Equivalent |
| K021278 | EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE | Sep 6, 2002 | Substantially Equivalent |
| K013640 | EG-3630UR, ULTRASUND VIDEO GASTROSCOPE | Feb 4, 2002 | Substantially Equivalent |
| K010740 | FG-36UX, FIBER ULTRASOUND GASTROSCOPE | Apr 17, 2001 | Substantially Equivalent |