FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE ORIGINAL PULSE-PAK
K Number: K892639
·
Decision Oct 5, 1989
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
69
Applicant Total
1
Review Days
176
Basic Information
- Device Name
- THE ORIGINAL PULSE-PAK
- K Number
- K892639
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- JONES SALES CO.
- Date Received
- April 12, 1989
- Decision Date
- October 5, 1989
- Product Code
- NFB
- 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 |
|---|---|---|---|
| NFB | Conserver, Oxygen | FDA class 2 | Anesthesiology |
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