ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)— 510(k) K232015
Substantially EquivalentAtmos Medizintechnik GmbH & Co. KG
FDA 510(k) clearance K232015 for ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0), Substantially Equivalent on 2023-08-03. Applicant: Atmos Medizintechnik GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Atmos Medizintechnik GmbH & Co. KG
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenzkirch, DE
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More clearances from Atmos Medizintechnik GmbH & Co. KG
view allAdverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.