OCM-G1 Attachment— 510(k) K180063
Substantially EquivalentThe Anspach Effort, Inc.
FDA 510(k) clearance K180063 for OCM-G1 Attachment, Substantially Equivalent on 2018-03-27. Applicant: The Anspach Effort, Inc..
Clearance details
- Applicant
- The Anspach Effort, Inc.
- Product code
- Code ERL
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Palm Beach Gardens, FL, US
Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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.