FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATIENT MONITOR #404
K Number: K831319
·
Decision Mar 22, 1984
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
46
Applicant Total
32
Review Days
335
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Basic Information
- Device Name
- PATIENT MONITOR #404
- K Number
- K831319
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Analogic Corp.
- Date Received
- April 22, 1983
- Decision Date
- March 22, 1984
- Product Code
- KLK
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K050919 | LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P | Jun 14, 2005 | Substantially Equivalent |
| K043025 | SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 | Nov 19, 2004 | Substantially Equivalent |
| K041434 | C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS | Aug 6, 2004 | Substantially Equivalent |
| K041376 | C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A | Jul 20, 2004 | Substantially Equivalent |
| K040995 | SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 | May 25, 2004 | Substantially Equivalent |
| K033345 | AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS | Nov 19, 2003 | Substantially Equivalent |
| K030931 | C3 PATIENT MONITOR | May 9, 2003 | Substantially Equivalent |
| K011304 | OB-1 FETAL MONITOR | May 29, 2001 | Substantially Equivalent |