FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANESTHESIA & BRAIN MONITOR
K Number: K821910
·
Decision Sep 7, 1982
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
74
Applicant Total
55
Review Days
71
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Basic Information
- Device Name
- ANESTHESIA & BRAIN MONITOR
- K Number
- K821910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Datex Division Instrumentarium Corp.
- Date Received
- June 28, 1982
- Decision Date
- September 7, 1982
- Product Code
- IKN
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| IKN | Electromyograph, Diagnostic | FDA class 2 | Physical Medicine |
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| K943456 | AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT | Oct 17, 1994 | Substantially Equivalent |
| K923172 | ANAESTHESIA RECORD KEEPER | Aug 9, 1994 | Substantially Equivalent |
| K935477 | AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD | Aug 1, 1994 | Substantially Equivalent |
| K943457 | AS/3 PRESSURE TEMPERATURE MODULE, M-PT | Jul 27, 1994 | Substantially Equivalent |