FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LINK TO ACUITY CLINICIAN NOTIFIER
K Number: K070204
·
Decision Mar 23, 2007
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
116
Applicant Total
7
Review Days
60
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Basic Information
- Device Name
- LINK TO ACUITY CLINICIAN NOTIFIER
- K Number
- K070204
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welch Allyn Protocol, Inc.
- Date Received
- January 22, 2007
- Decision Date
- March 23, 2007
- Product Code
- MSX
- 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 |
|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | FDA class 2 | Cardiovascular |
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Other Clearances by Welch Allyn Protocol, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063419 | MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) | Dec 4, 2006 | Substantially Equivalent |
| K033378 | VITAL SIGNS MONITOR, PROPAQ LT | Mar 1, 2004 | Substantially Equivalent |
| K031740 | VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES | Aug 26, 2003 | Substantially Equivalent |
| K022453 | MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM | Aug 21, 2002 | Substantially Equivalent |
| K021681 | MICROPAQ, MODELS 402, 404 | Jul 23, 2002 | Substantially Equivalent |
| K012451 | PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 | Aug 20, 2001 | Substantially Equivalent |