510(k) K003894 ยท BZD Ventilator, Non-Continuous (Respirator)
ORACLE ORAL MASK
| Applicant | Fisher & Paykel Healthcare, Ltd., East Tamaki, Auckland, NZ |
| Decision | Substantially Equivalent, Jun 25, 2001 |
| Received | Dec 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003894
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A, HC431SLL, HC431SLM & HC431SLS. CPAP masks. Terminated |
BZD | None listed |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A & 900HC401. CPAP masks. Terminated |
BZD | None listed |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL & HC407U. CPAP masks. Terminated |
BZD | None listed |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks. Terminated |
BZD | None listed |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A & HC452F. CPAP masks. Terminated |
BZD | None listed |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuser holes),400HC203 (Elbow + vent NR valve), 400HC209 (Oracle 452 flexitube kit vent NR), 400HC502 (HC407 mask n Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.