Atmos E 201 Thorax and Atmos S 201 Thorax
FDA 510(k) K103042 · Atmos, Inc.
510(k) numberK103042
Submission
- Device name
- Atmos E 201 Thorax and Atmos S 201 Thorax
- Applicant
- Atmos, Inc.
Allentown, PA, US - Received
- October 14, 2010
- Decision date
- April 15, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Atmos E 201 Thorax and Atmos S 201 Thorax cleared by the FDA?
Atmos E 201 Thorax and Atmos S 201 Thorax (K103042) received a 510(k) decision of Substantially Equivalent on April 15, 2011, 183 days after the submission was received.
What is the product code of K103042?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.