MED2000 SPA Nebulizer Andyflow, Model A1/C with Accessories

Q: What is the product code of K041327?

The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.

FDA 510(k) K041327 · Med2000 S.R.L.

Substantially Equivalent

510(k) numberK041327

Submission

Device name: MED2000 SPA Nebulizer Andyflow, Model A1/C with Accessories
Applicant: Med2000 S.R.L.
Great Neck, NY, US
Received: May 18, 2004
Decision date: July 20, 2004
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

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
K041974	MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerBTI · Special	08/24/2004SE
K031908	MED2000 SPA Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 SPA…CAF · Traditional	01/14/2004SE

Questions and answers

When was MED2000 SPA Nebulizer Andyflow, Model A1/C with Accessories cleared by the FDA?

MED2000 SPA Nebulizer Andyflow, Model A1/C with Accessories (K041327) received a 510(k) decision of Substantially Equivalent on July 20, 2004, 63 days after the submission was received.

What is the product code of K041327?

The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.