Question 1

Who is the manufacturer of SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050?

Accepted Answer

San UP S.A. filed the 510(k) submission for SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 (K002468).

Question 2

What is the FDA product code for SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050?

Accepted Answer

BTI. It is classified under 21 CFR 868.6250 as a Class 2 device in the Anesthesiology panel.

Question 3

When was SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 cleared by the FDA?

Accepted Answer

Mar 2, 2001 (decision: SESE).

Question 4

What is the regulatory pathway for SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K002468
Device Name	SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050
Applicant	San UP S.A.
Product Code	BTI · Anesthesiology
Decision Date	Mar 2, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.6250
Device Class	Class 2

SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050

Device Facts

Regulatory Classification

Identification

Special Controls