FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
K Number: K971501
·
Decision Oct 14, 1997
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
45
Review Days
173
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Basic Information
- Device Name
- SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
- K Number
- K971501
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Logic Systems Corp.
- Date Received
- April 24, 1997
- Decision Date
- October 14, 1997
- Product Code
- MNR
- 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K031352 | BIO-LOGIC INSERT EARPHONES | Jul 16, 2003 | Substantially Equivalent |
| K030907 | STACKED ABR FOR NAVIGATOR PRO | May 9, 2003 | Substantially Equivalent |
| K031009 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM | Apr 28, 2003 | Substantially Equivalent |
| K021895 | BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM | Jul 1, 2002 | Substantially Equivalent |
| K021801 | BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS | Jun 27, 2002 | Substantially Equivalent |