FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCANNING DIRECTOR
K Number: K944585
·
Decision Feb 21, 1995
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
23
Applicant Total
9
Review Days
155
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Basic Information
- Device Name
- SCANNING DIRECTOR
- K Number
- K944585
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3725
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Prentke Romich Co.
- Date Received
- September 19, 1994
- Decision Date
- February 21, 1995
- Product Code
- IQA
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IQA | System, Environmental Control, Powered | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
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Other Clearances by Prentke Romich Co.
| K Number | Device Name | ||
|---|---|---|---|
| K961306 | DELTATALKER WITH INFRARED | Jun 27, 1996 | Substantially Equivalent |
| K933207 | WALKERTALKER | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K935317 | ALPHA TALKER | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K925387 | LIBERATOR | Mar 29, 1993 | Substantially Equivalent |
| K925527 | LIGHT TALKER | Mar 22, 1993 | Substantially Equivalent |
| K914259 | TOUCH TALKER | Feb 27, 1992 | Substantially Equivalent |
| K902664 | HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 | Jul 25, 1990 | Substantially Equivalent |
| K902206 | CONTROL 1 ENVIRONMENTAL CONTROL | May 29, 1990 | Substantially Equivalent |