ORACLE ORAL MASK
FDA 510(k) clearance K003894 · decided 2001-06-25
Clearance details
- K-number
- K003894
- Device name
- ORACLE ORAL MASK
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-18
- Decision date
- 2001-06-25
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- BZD
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- East Tamaki, Auckland, NZ
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A, HC431SLL, HC431SLM & HC431 recall (Z-0969-2007) | Fisher & Paykel Healthcare Inc | 2007-06-27 |
| Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A & 900HC401. CPAP masks. recall (Z-0970-2007) | Fisher & Paykel Healthcare Inc | 2007-06-27 |
| Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC40 recall (Z-0971-2007) | Fisher & Paykel Healthcare Inc | 2007-06-27 |
| Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks. recall (Z-0972-2007) | Fisher & Paykel Healthcare Inc | 2007-06-27 |
| Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A & HC45 recall (Z-0973-2007) | Fisher & Paykel Healthcare Inc | 2007-06-27 |
| Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuse recall (Z-0974-2007) | Fisher & Paykel Healthcare Inc | 2007-06-27 |