ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT— 510(k) K951423
Substantially EquivalentImpact Instrumentation, Inc.
FDA 510(k) clearance K951423 for ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT, Substantially Equivalent on 1995-04-18. Applicant: Impact Instrumentation, Inc.. Device class: 2.
Clearance details
- Applicant
- Impact Instrumentation, Inc.
- 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
- West Caldwell, NJ, US
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 Impact Instrumentation, Inc.
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.