FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
CM 7000MR
K Number: K890010
·
Decision Jun 12, 1989
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
3
Review Days
160
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
- CM 7000MR
- K Number
- K890010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Trudell Medical
- Date Received
- January 3, 1989
- Decision Date
- June 12, 1989
- Product Code
- CAP
- 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 |
|---|---|---|---|
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAP), ordered by most recent decision date.
SINGLE USE MANOMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
VORTRAN APM-Plus
FDA 510(k)
FDA Class 2
·Anesthesiology
NS 120P-TRS Airway Pressure Gauge
FDA 510(k)
FDA Class 2
·Anesthesiology
NAPA LP-15 Airway Pressure Monitor
FDA 510(k)
FDA Class 2
·Anesthesiology
VORTRAN Manometer
FDA 510(k)
FDA Class 2
·Anesthesiology
Disposable Pressure Manometer (DPM)
FDA 510(k)
FDA Class 2
·Anesthesiology