FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAZOOKA SYSTEM
K Number: K951469
·
Decision Jun 28, 1995
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
22
Review Days
90
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
- BAZOOKA SYSTEM
- K Number
- K951469
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Medical Systems, Inc.
- Date Received
- March 30, 1995
- Decision Date
- June 28, 1995
- Product Code
- FNM
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FNM), ordered by most recent decision date.
PRESSURE GUARD SITE SELECT (A)
FDA 510(k)
FDA Class 2
·General Hospital
MIGHTY AIR
FDA 510(k)
FDA Class 2
·General Hospital
ZAK-2000
FDA 510(k)
FDA Class 2
·General Hospital
PHYSIO/1000
FDA 510(k)
FDA Class 2
·General Hospital
SIMPULSE
FDA 510(k)
FDA Class 2
·General Hospital
SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Innovative Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973035 | VIOLA II DENTAL CAMERA SYSTEM | Sep 24, 1997 | Substantially Equivalent |
| K933184 | POSITIVE AIRWAY PRESSURE SYSTEM | Nov 28, 1994 | Substantially Equivalent |
| K924590 | MICROWAVE AUTOMATED TISSUE PROCESSOR | Dec 29, 1992 | Substantially Equivalent |
| K922081 | LABOTECH AUTOMATED MICROTITER ANALYZER | Sep 2, 1992 | Substantially Equivalent |
| K921005 | AUTOLOADER | Apr 29, 1992 | Substantially Equivalent |
| K915457 | PHACO 20/20 SYSTEM I | Feb 24, 1992 | Substantially Equivalent |
| K915456 | PHACO 3000 LINEAR | Feb 12, 1992 | Substantially Equivalent |
| K883599 | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | Sep 2, 1988 | Substantially Equivalent |
| K880745 | LX-100 SLIDE STAINER | Apr 27, 1988 | Substantially Equivalent |
| K853938 | LX 300 TISSUE PROCESSOR | Oct 10, 1985 | Substantially Equivalent |