FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT
K Number: K981167
·
Decision Jun 18, 1998
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
8
Review Days
78
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Basic Information
- Device Name
- STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT
- K Number
- K981167
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dhd Healthcare Corp.
- Date Received
- April 1, 1998
- Decision Date
- June 18, 1998
- Product Code
- CAF
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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|---|---|---|---|
| K040718 | TRUST | Apr 2, 2004 | Substantially Equivalent |
| K002768 | ACAPELLA | Dec 5, 2000 | Substantially Equivalent |
| K003146 | CLINIFLO INCENTIVE SPIROMETER | Nov 21, 2000 | Substantially Equivalent |
| K991561 | ROADRUNNER, PEP THERAPY DEVICE | Nov 10, 1999 | Substantially Equivalent |
| K991300 | BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE | Jul 12, 1999 | Substantially Equivalent |
| K983467 | THERAPEP | Apr 2, 1999 | Substantially Equivalent |
| K980662 | LICHEN, BACTERIAL IN LINE BREATHING FILTER | Sep 14, 1998 | Substantially Equivalent |