FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LARYNGOSCOPE ATTACHMENT PH2000
K Number: K831255
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
20
Applicant Total
10
Review Days
147
Basic Information
- Device Name
- LARYNGOSCOPE ATTACHMENT PH2000
- K Number
- K831255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- EDER INSTRUMENT CO, INC.
- Date Received
- April 18, 1983
- Decision Date
- September 12, 1983
- Product Code
- EQN
- 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 |
|---|---|---|---|
| EQN | Laryngoscope, Nasopharyngoscope | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by EDER INSTRUMENT CO, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K843498 | BIPOLAR SUCTION ELECTRODE | Dec 14, 1984 | Substantially Equivalent |
| K843497 | SURGICAL KNIVES & PROBES | Oct 31, 1984 | Substantially Equivalent |
| K843499 | ARTHROSCOPY LEG HOLDER | Oct 31, 1984 | Substantially Equivalent |
| K831240 | LASER BRONCHOSCOPE | Jul 26, 1983 | Substantially Equivalent |
| K831241 | LASER LAPARAXOPE | Jun 10, 1983 | Substantially Equivalent |
| K822959 | ENDOSCOPIC VIDEOSYSTEM | Oct 22, 1982 | Substantially Equivalent |
| K802479 | SURGICAL KNIVES & PROBES | Oct 31, 1980 | Substantially Equivalent |
| K792100 | GRASPING FORCEP (W/FOUR PRONGS) | Nov 13, 1979 | Substantially Equivalent |
| K791052 | ENDOSCOPIC INSTRUMENT | Aug 3, 1979 | Substantially Equivalent |