FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HA-2000 REAL EAR SPECTROSCOPE
K Number: K862026
·
Decision Aug 15, 1986
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
45
Applicant Total
2
Review Days
79
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Basic Information
- Device Name
- HA-2000 REAL EAR SPECTROSCOPE
- K Number
- K862026
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3310
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- And/Or Corp.
- Date Received
- May 28, 1986
- Decision Date
- August 15, 1986
- Product Code
- ETW
- 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 |
|---|---|---|---|
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by And/Or Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K851143 | RHINOMANOMETERS NR3, NR4 | May 23, 1985 | Substantially Equivalent |