FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WHISTLE WATCH
K Number: K980550
·
Decision Aug 27, 1998
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
79
Applicant Total
4
Review Days
196
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Basic Information
- Device Name
- WHISTLE WATCH
- K Number
- K980550
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Harwill Medical (Pty) , Ltd.
- Date Received
- February 12, 1998
- Decision Date
- August 27, 1998
- Product Code
- BZH
- 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 |
|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | FDA class 2 | Anesthesiology |
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