FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEONATAL SCREENING AUDIOMETER
K Number: K780150
·
Decision Feb 13, 1978
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
234
Applicant Total
14
Review Days
14
Basic Information
- Device Name
- NEONATAL SCREENING AUDIOMETER
- K Number
- K780150
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- TELEDIAGNOSTIC SYSTEMS, INC.
- Date Received
- January 30, 1978
- Decision Date
- February 13, 1978
- Product Code
- EWO
- 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 |
|---|---|---|---|
| EWO | Audiometer | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by TELEDIAGNOSTIC SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| K904328 | VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM | Jun 18, 1991 | Substantially Equivalent |
| K904222 | VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER | Jan 18, 1991 | Substantially Equivalent |
| K885328 | RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER | Mar 22, 1989 | Substantially Equivalent |
| K884891 | OC-100 OXIMETER INTERFACE CALIBRATOR | Dec 28, 1988 | Substantially Equivalent |
| K883947 | ISO-100 ISOLATION AMPLIFIER | Dec 5, 1988 | Substantially Equivalent |
| K874257 | S-10 TELEPHONIC POLYSOMNOGRAPH | Dec 11, 1987 | Substantially Equivalent |
| K871120 | M10 EEG MONITOR SCOPE | May 1, 1987 | Substantially Equivalent |