Siemens Servo Ultra Nebulizer 345
FDA 510(k) K960854 · Pacesetter, Inc.
510(k) numberK960854
Submission
- Device name
- Siemens Servo Ultra Nebulizer 345
- Applicant
- Pacesetter, Inc.
North Attleboro, MA, US - Received
- March 1, 1996
- Decision date
- December 23, 1996
- 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
Other 510(k)s with product code CAF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)CAF · Traditional | FindAir Sp. z o.o. | 06/02/2026SE |
| K251572 | eRapid with eTrack SystemCAF · Traditional | Pari Respiratory Equipment, Inc. | 12/19/2025SE |
| K251659 | Mesh Nebulizer (H6)CAF · Traditional | Qingdao Future Medical Technology Co., Ltd. | 11/14/2025SE |
| K244035 | Portable mesh nebulizer (JM821)CAF · Traditional | Shenzhen Jermei Medical Device Technology Co.… | 09/19/2025SE |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer…CAF · Traditional | Joytech Healthcare Co. , Ltd. | 07/02/2025SE |
| K250022 | HeroTracker SenseCAF · Traditional | Voluntis | 06/30/2025SE |
| K250583 | AdheResp Smart Breath-actuated Mesh NebulizerCAF · Traditional | Hcmed Innovations Co., Ltd. | 06/20/2025SE |
| 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 |
More from Aerogen, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K972814 | Locator Model 4036DTB · Traditional | 02/23/1998ST |
| K954714 | Afp Cardiac Pacing System Model 283 (Modification)DTB · Traditional | 02/01/1996ST |
| K954551 | DF-1 Terminal CapDTB · Traditional | 12/26/1995ST |
| K952206 | Passive Plus Pacing Leads with Titanium Nitride CoatingDTB · Traditional | 08/31/1995SESP |
| K951950 | Passive Plus Pacing Leads with Titanium Nitride CoatingDTB · Traditional | 08/31/1995SESP |
| K951087 | Tendril, Unipolar Endocardial Screw-In LeadDTB · Traditional | 06/29/1995ST |
| K950140 | IS-1/QUADRIPOLAR Terminal Cap, Part Number 6011069DTD · Traditional | 04/06/1995SE |
Questions and answers
When was Siemens Servo Ultra Nebulizer 345 cleared by the FDA?
Siemens Servo Ultra Nebulizer 345 (K960854) received a 510(k) decision of Substantially Equivalent on December 23, 1996, 297 days after the submission was received.
What is the product code of K960854?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.