FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEAN PRESSURE MONITOR
K Number: K810255
·
Decision Feb 12, 1981
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
35
Review Days
13
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
- MEAN PRESSURE MONITOR
- K Number
- K810255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Healthdyne, Inc.
- Date Received
- January 30, 1981
- Decision Date
- February 12, 1981
- 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
Other Clearances by Healthdyne, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950331 | PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) | Sep 21, 1995 | Substantially Equivalent |
| K922106 | ALICE | Jul 6, 1994 | Substantially Equivalent |
| K942357 | H-500 ALLIANCE OXYGEN CONCENTRATOR | May 27, 1994 | Substantially Equivalent |
| K934502 | FLOW SPIROMETER | Apr 4, 1994 | Substantially Equivalent |
| K924146 | OH-500 OXYGEN CONCENTRATOR | Jan 7, 1993 | Substantially Equivalent |
| K922623 | NEBULIZER SYSTEM | Dec 1, 1992 | Substantially Equivalent |
| K910118 | DATA RECORDER | Feb 14, 1991 | Substantially Equivalent |
| K903287 | MODEL 900S APNEA/HEART MONITOR | Aug 17, 1990 | Substantially Equivalent |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | Jan 22, 1990 | Substantially Equivalent |
| K892006 | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S | May 23, 1989 | Substantially Equivalent |