FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDGRAPHICS ULTIMA SYSTEM
K Number: K061731
·
Decision Sep 6, 2006
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
32
Applicant Total
23
Review Days
78
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
- MEDGRAPHICS ULTIMA SYSTEM
- K Number
- K061731
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.1730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Graphics Corp.
- Date Received
- June 20, 2006
- Decision Date
- September 6, 2006
- Product Code
- BZL
- 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 |
|---|---|---|---|
| BZL | Computer, Oxygen-Uptake | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZL), ordered by most recent decision date.
Breezing Med
FDA 510(k)
FDA Class 2
·Anesthesiology
NICU V'02
FDA 510(k)
FDA Class 2
·Anesthesiology
ANASCIENT BREATH MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
METAPHOR METABOLIC MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
FITMATE SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
EXPRESS SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Medical Graphics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K152585 | Resmon PRO FULL | Jun 24, 2016 | Substantially Equivalent |
| K070858 | EXPRESS SERIES | Apr 16, 2007 | Substantially Equivalent |
| K955432 | CPX, CCM, CATH WITH 15% CO2 | Jul 1, 1996 | Substantially Equivalent |
| K943259 | 1085 ULTIMATE E PLETHYSMOGRAPH | Apr 10, 1995 | Substantially Equivalent |
| K923209 | MEDGRAPHICS EXERCISE CONSULT | Mar 11, 1993 | Substantially Equivalent |
| K912906 | MEDGRAPHICS PF/DX | Feb 4, 1992 | Substantially Equivalent |
| K896345 | EXERCISE EVALUATION SYSTEM 2010 | Jan 20, 1990 | Substantially Equivalent |
| K896396 | MIDA SYSTEM, MODELS 1000/1100 | Jan 18, 1990 | Substantially Equivalent |
| K874925 | CPE 2000 CARDIO PULMONARY ERGOMETER | Jan 19, 1988 | Substantially Equivalent |
| K871711 | MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM | Sep 25, 1987 | Substantially Equivalent |