FAHL TRACHEOSTOMY TUBES (MULTIPLE)
FDA 510(k) clearance K123699 · decided 2013-08-12
Clearance details
- K-number
- K123699
- Device name
- FAHL TRACHEOSTOMY TUBES (MULTIPLE)
- Applicant
- Andreas Fahl Medizintechnik-Vertrieb GmbH
- Decision
- Substantially Equivalent
- Date received
- 2012-12-03
- Decision date
- 2013-08-12
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- JOH
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Koeln, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.