FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFEBED PATIENT VIGILANCE SYSTEM
K Number: K082366
·
Decision Sep 26, 2008
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
5
Review Days
39
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Basic Information
- Device Name
- LIFEBED PATIENT VIGILANCE SYSTEM
- K Number
- K082366
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hoana Medical, Inc.
- Date Received
- August 18, 2008
- Decision Date
- September 26, 2008
- Product Code
- DRT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by Hoana Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100745 | LIFEBED NETWORK PATIENT VIGILANCE SYSTEM | Apr 15, 2010 | Substantially Equivalent |
| K092037 | LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM | Oct 2, 2009 | Substantially Equivalent |
| K083534 | LIFEBED NETWORK PATIENT VIGILANCE SYSTEM | Apr 13, 2009 | Substantially Equivalent |
| K052446 | LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM | Feb 2, 2006 | Substantially Equivalent |