FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOMMED OBSERVER, MODEL I
K Number: K003180
·
Decision Jun 28, 2001
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
8
Review Days
260
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Basic Information
- Device Name
- HOMMED OBSERVER, MODEL I
- K Number
- K003180
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hommed, LLC
- Date Received
- October 11, 2000
- Decision Date
- June 28, 2001
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Hommed, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K040799 | HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS | Aug 18, 2004 | Substantially Equivalent |
| K040651 | HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM | Aug 10, 2004 | Substantially Equivalent |
| K040032 | CENTRAL STATION, VERSION 3.3H | Feb 27, 2004 | Substantially Equivalent |
| K020184 | HOMMED CENTRAL STATION | Apr 22, 2002 | Substantially Equivalent |
| K014025 | HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER | Apr 9, 2002 | Substantially Equivalent |
| K004044 | HOMMED SENTRY III PATIENT MONITOR SYSTEM | Mar 2, 2001 | Substantially Equivalent |
| K993938 | THE HOMMED SENTRY, MODEL 1 SENTRY | Mar 15, 2000 | Substantially Equivalent |