FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT
K Number: K952691
·
Decision Jul 31, 1995
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
111
Review Days
49
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Basic Information
- Device Name
- WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT
- K Number
- K952691
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welch Allyn, Inc.
- Date Received
- June 12, 1995
- Decision Date
- July 31, 1995
- Product Code
- FJC
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FJC | Detector, Blood Level | FDA class 2 | Gastroenterology, Urology |
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| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | Dec 19, 2014 | Substantially Equivalent |
| K132807 | MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) | Jan 31, 2014 | Substantially Equivalent |
| K132808 | VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR | Nov 20, 2013 | Substantially Equivalent |