FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPAG PAK
K Number: K896608
·
Decision Apr 9, 1990
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
10
Applicant Total
5
Review Days
139
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SPAG PAK
- K Number
- K896608
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Viratek, Inc.
- Date Received
- November 21, 1989
- Decision Date
- April 9, 1990
- Product Code
- BYL
- 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 |
|---|---|---|---|
| BYL | Tent, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYL), ordered by most recent decision date.
NASCOR IGLOO
FDA 510(k)
FDA Class 1
·Anesthesiology
NASCOR OXYDOME
FDA 510(k)
FDA Class 1
·Anesthesiology
DIRD INGANT O2 (BIO 2 HOOD)
FDA 510(k)
FDA Class 1
·Anesthesiology
NOVA OXYGEN TENT
FDA 510(k)
FDA Class 1
·Anesthesiology
KEYSTONE OXYGEN TENT
FDA 510(k)
FDA Class 1
·Anesthesiology
AEROSOL DELIVERY HOOD
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Viratek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882396 | AEROSOL DELIVERY HOOD | Aug 1, 1988 | Substantially Equivalent |
| K870051 | SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE | Oct 6, 1987 | Substantially Equivalent |
| K871427 | (SPAG) MODEL SPAG-2 6000 SERIES | Oct 6, 1987 | Unknown |
| K843717 | VIRATEK SMALL PARTICLE AEROSOL GENERAT | Dec 30, 1985 | Substantially Equivalent |