Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
FDA 510(k) clearance K190173 · decided 2019-05-10
Clearance details
- K-number
- K190173
- Device name
- Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
- Applicant
- Jk-Holding GmbH
- Decision
- Substantially Equivalent
- Date received
- 2019-02-01
- Decision date
- 2019-05-10
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- LEJ
- Device class
- 2
- Regulation number
- 878.4635
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Windhagen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.