FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXHTR-1
K Number: K894654
·
Decision Aug 1, 1990
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
35
Review Days
373
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Basic Information
- Device Name
- FLEXHTR-1
- K Number
- K894654
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5270
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Bird Products Corp.
- Date Received
- July 24, 1989
- Decision Date
- August 1, 1990
- Product Code
- BZE
- 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 |
|---|---|---|---|
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZE), ordered by most recent decision date.
inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)
FDA 510(k)
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Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line
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VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
FDA 510(k)
FDA Class 2
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Other Clearances by Bird Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K032451 | BIRD TBIRD VELA VENTILATOR | Mar 17, 2004 | Substantially Equivalent |
| K022674 | BIRD AVEA VENTILATOR | Nov 6, 2002 | Substantially Equivalent |
| K013642 | AVEA | May 22, 2002 | Substantially Equivalent |
| K020730 | ORION NASAL CPAP SYSTEM | May 22, 2002 | Substantially Equivalent |
| K020746 | BIRD TBIRD VELA VENTILATOR | Apr 22, 2002 | Substantially Equivalent |
| 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. |