Companion 318 Nasal CPAP System -- Modification
FDA 510(k) K922178 · Puritan Bennett Corp.
510(k) numberK922178
Submission
- Device name
- Companion 318 Nasal CPAP System -- Modification
- Applicant
- Puritan Bennett Corp.
Lenexa, KS, US - Received
- May 8, 1992
- Decision date
- May 29, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5965
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Companion 318 Nasal CPAP System -- Modification cleared by the FDA?
Companion 318 Nasal CPAP System -- Modification (K922178) received a 510(k) decision of Substantially Equivalent on May 29, 1992, 21 days after the submission was received.
What is the product code of K922178?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.