Stealth Pilot Kit/ Stealth Spacer/Face Mask Kit
FDA 510(k) K981167 · Dhd Healthcare Corp.
510(k) numberK981167
Submission
- Device name
- Stealth Pilot Kit/ Stealth Spacer/Face Mask Kit
- Applicant
- Dhd Healthcare Corp.
Wampsville, NY, US - Received
- April 1, 1998
- Decision date
- June 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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| K242354 | AllNEBCAF · Traditional | Enchant Tek Co. , Ltd. | 04/29/2025SE |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special | Thayer Medical Corporation | 06/18/2024SE |
| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | Aerogen, Ltd. | 05/10/2024SE |
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| K991561 | Roadrunner, Pep Therapy DeviceBWF · Traditional | 11/10/1999SE |
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| K983467 | TherapepBWF · Traditional | 04/02/1999SE |
| K980662 | Lichen, Bacterial in Line Breathing FilterCAH · Traditional | 09/14/1998SE |
Questions and answers
When was Stealth Pilot Kit/ Stealth Spacer/Face Mask Kit cleared by the FDA?
Stealth Pilot Kit/ Stealth Spacer/Face Mask Kit (K981167) received a 510(k) decision of Substantially Equivalent on June 18, 1998, 78 days after the submission was received.
What is the product code of K981167?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.