FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EDENTEC MODEL 2860 PRESSURE METER
K Number: K891540
·
Decision Jun 1, 1989
Classifications
1
FEI Numbers
71
Registration Numbers
72
Same Product Code
79
Applicant Total
18
Review Days
76
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
- EDENTEC MODEL 2860 PRESSURE METER
- K Number
- K891540
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5965
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Edentec Corp.
- Date Received
- March 17, 1989
- Decision Date
- June 1, 1989
- Product Code
- BYE
- 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 |
|---|---|---|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYE), ordered by most recent decision date.
Besmed PEEP Valve
FDA 510(k)
FDA Class 2
·Anesthesiology
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
FDA 510(k)
FDA Class 2
·Anesthesiology
B&B BUBBLER
FDA 510(k)
FDA Class 2
·Anesthesiology
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
O_TWO CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
WATERPAP VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Edentec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K953363 | OXIFLOW DIGITAL RECORDER | Feb 6, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K953540 | EEE | Aug 25, 1995 | Substantially Equivalent |
| K921819 | EDENTEC MODEL 3710 I DIGITAL PRINTER | Oct 22, 1993 | Substantially Equivalent |
| K913749 | EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 | Jul 2, 1992 | Substantially Equivalent |
| K910871 | EDENTEC DIGITAL CHARTER MODEL 3710 | Aug 29, 1991 | Substantially Equivalent |
| K910870 | EDENTEC MODEL 3711 DIGITAL RECORDER | Aug 29, 1991 | Substantially Equivalent |
| K905575 | MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON | Jun 20, 1991 | Substantially Equivalent |
| K901060 | EDENTEC MODEL 2000W SYSTEM 700 MONITOR | May 15, 1990 | Substantially Equivalent |
| K893561 | EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. | Aug 25, 1989 | Substantially Equivalent |
| K892227 | EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) | Jun 20, 1989 | Substantially Equivalent |