FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SALTER LABS MODEL #1015
K Number: K903539
·
Decision Dec 17, 1990
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
46
Applicant Total
48
Review Days
132
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Basic Information
- Device Name
- SALTER LABS MODEL #1015
- K Number
- K903539
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5770
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Salter Labs
- Date Received
- August 7, 1990
- Decision Date
- December 17, 1990
- Product Code
- CBH
- 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 |
|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | FDA class 1 | Anesthesiology |
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