ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764— 510(k) K971827
Substantially EquivalentAlexander Mfg. Co.
FDA 510(k) clearance K971827 for ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764, Substantially Equivalent on 1997-08-12. Applicant: Alexander Mfg. Co.. Device class: 2.
Clearance details
- Applicant
- Alexander Mfg. Co.
- Product code
- Code DQA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mason City, IA, US
Recent devices under product code DQA
view all- K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
- K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K252448 — AViTA Pulse Oximeter (SP61)
More clearances from Alexander Mfg. Co.
view all- K982896 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9
- K981776 — ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X
- K981728 — ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
- K980224 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822
- K974061 — RECHARGEABLE BATTERY PART NUMBER GL825-200
Adverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
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.