FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYPEX
K Number: K895274
·
Decision Feb 23, 1990
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
1
Applicant Total
1
Review Days
184
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Basic Information
- Device Name
- HYPEX
- K Number
- K895274
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5675
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Global Business, Inc.
- Date Received
- August 23, 1989
- Decision Date
- February 23, 1990
- Product Code
- BYW
- 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 |
|---|---|---|---|
| BYW | Device, Rebreathing | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYW), ordered by most recent decision date.
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