FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
K Number: K913749
·
Decision Jul 2, 1992
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
18
Review Days
316
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Basic Information
- Device Name
- EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
- K Number
- K913749
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Edentec Corp.
- Date Received
- August 21, 1991
- Decision Date
- July 2, 1992
- Product Code
- BZQ
- 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
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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 |
| 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 |
| K891540 | EDENTEC MODEL 2860 PRESSURE METER | Jun 1, 1989 | Substantially Equivalent |