MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057— 510(k) K021368
Substantially EquivalentMedela AG
FDA 510(k) clearance K021368 for MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057, Substantially Equivalent on 2002-05-15. Applicant: Medela AG. Device class: 2.
Clearance details
- Applicant
- Medela AG
- Product code
- Code BTA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ch-6340 Baar, CH
Recent devices under product code BTA
view all- K253629 — Momcozy Nasal Aspirator (BN007)
- K260134 — Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02 +1 more
- K260892 — Suction Pump (SU-90)
- K260473 — Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
- K253107 — Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
More clearances from Medela AG
view allAdverse events under product code BTA
product code BTA- Death
- 5
- Total
- 5
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.