FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAMM-AIRE CP
K Number: K893681
·
Decision Jul 20, 1989
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
13
Review Days
65
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
- MAMM-AIRE CP
- K Number
- K893681
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Custom Medical Products, Ltd.
- Date Received
- May 16, 1989
- Decision Date
- July 20, 1989
- Product Code
- IZO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZO), ordered by most recent decision date.
MPH50, MPH65, AND MPH80
FDA 510(k)
FDA Class 1
·Radiology
HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
FDA 510(k)
FDA Class 1
·Radiology
N 800 HF
FDA 510(k)
FDA Class 1
·Radiology
SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
FDA 510(k)
FDA Class 1
·Radiology
MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR
FDA 510(k)
FDA Class 1
·Radiology
POLYDOROS SX 65 AND 80
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Custom Medical Products, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K931417 | STERILE EQUIPMENT COVERS | Jul 6, 1995 | Substantially Equivalent |
| K931456 | SURGICAL DRAPE AND GOWN TRAY | Jul 8, 1994 | Substantially Equivalent |
| K931418 | SURGICAL DRAPE | May 5, 1994 | Substantially Equivalent |
| K931455 | HEAD SHEET | May 5, 1994 | Substantially Equivalent |
| K930815 | ABDOMINAL / THORACIC PATIENT DRAPE | May 5, 1994 | Substantially Equivalent |
| K931844 | CUSTOM PROCEDURE MEDICAL TRAY OR KIT | Jan 25, 1994 | Unknown |
| K926519 | SURGICAL GOWN | Aug 12, 1993 | Substantially Equivalent |
| K900847 | ENEMA KIT 'Y' DESIGN | Apr 13, 1990 | Substantially Equivalent |
| K900848 | ENEMA KIT 'STRAIGHT' DESIGN | Apr 13, 1990 | Substantially Equivalent |
| K895084 | APERTURE | Oct 27, 1989 | Substantially Equivalent |