FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BODY POSITION INDICATOR, MODEL BPI1
K Number: K940013
·
Decision May 4, 1995
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
7
Review Days
485
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Basic Information
- Device Name
- BODY POSITION INDICATOR, MODEL BPI1
- K Number
- K940013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pro-Tech, Inc.
- Date Received
- January 4, 1994
- Decision Date
- May 4, 1995
- 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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Other Clearances by Pro-Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940015 | SNORING MICROPHONE, SM1 | Jan 11, 1995 | Substantially Equivalent |
| K940014 | PLM SENSOR, MODEL PLM1 | Nov 10, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K924752 | FREEDOM OXIMETER/EEG DIGITAL INTERFACE | Sep 10, 1993 | Substantially Equivalent |
| K923402 | CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR | Dec 30, 1992 | Substantially Equivalent |
| K913396 | CANNULA STYLE THERMOCOUPLES | May 22, 1992 | Substantially Equivalent |
| K913395 | EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS | May 20, 1992 | Substantially Equivalent |