FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3MP-7 SCANNER RESPIRATORY MONITOR
K Number: K802565
·
Decision Oct 31, 1980
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
35
Review Days
14
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Basic Information
- Device Name
- 3MP-7 SCANNER RESPIRATORY MONITOR
- K Number
- K802565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Bird Products Corp.
- Date Received
- October 17, 1980
- Decision Date
- October 31, 1980
- 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 |
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| K003770 | BIRD TBIRD LEGACY VENTILATOR | Dec 15, 2000 | Substantially Equivalent - Subject to Tracking Reg. |
| K990856 | HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 | Jan 11, 2000 | Substantially Equivalent |
| K993449 | BIRD V.I.P. GOLD/STERLING | Dec 20, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K982580 | BIRD MONITOR INTERFACE | Oct 22, 1998 | Substantially Equivalent - Subject to Tracking Reg. |
| K981971 | TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3 | Aug 24, 1998 | Substantially Equivalent - Subject to Tracking Reg. |