Respiradyne Ii(Tm)
FDA 510(k) K863866 · Chesebrough-Pond'S U.S.A. Co.
510(k) numberK863866
Submission
- Device name
- Respiradyne Ii(Tm)
- Applicant
- Chesebrough-Pond'S U.S.A. Co.
Trumbull, CT, US - Received
- October 3, 1986
- Decision date
- January 28, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZK – Spirometer, Monitoring (W/Wo Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1850
- Specialty
- Anesthesiology
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| K192595 | ExSpiron 2XiBZK · Special | Respiratory Motion | 12/17/2019SE |
| K180788 | Gas Module 3BZK · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 10/24/2018SE |
| K173181 | ExSpiron 1XiBZK · Traditional | Respiratory Motion, Inc. | 03/16/2018SE |
| K162131 | ExSpiron 1XiBZK · Traditional | Respiratory Motion, Inc. | 05/09/2017SE |
| K130170 | Exspiron 1XIBZK · Special | Respiratory Motion, Inc. | 05/29/2013SE |
| K120087 | ExspironBZK · Traditional | Respiratory Motion, Inc. | 09/26/2012SE |
| K103578 | Philips NM3 Respiratory Monitor with VentassistBZK · Traditional | Respironics Novametrix, LLC | 06/02/2011SE |
| K091853 | Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014BZK · Traditional | Nspire Health, Inc. | 09/21/2009SE |
| K092217 | Mercury VCO2BZK · Special | Respironics Novametrix, Inc. | 08/21/2009SE |
More from Respironics Novametrix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K862803 | Chesebrough Pond's Hydrocolloid DressingFRO · Traditional | 11/14/1986SN |
| K851383 | Blisterfilm Transparent DressingNAD · Traditional | 07/05/1985SN |
| K851382 | Chesebrough-Pond's Sequential Wound DressingNAD · Traditional | 07/05/1985SN |
| K851539 | Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloKNT · Traditional | 06/12/1985SE |
| K843567 | Kangaroo Nasogastric Feeding TubeKNT · Traditional | 02/14/1985SE |
| K845010 | Chesebrough-Pond's Uri-Drain Male Urinary PouchEYQ · Traditional | 01/15/1985SE |
| K844186 | Continent Stoma System & AccessoriesKBG · Traditional | 01/15/1985SE |
| K844789 | Kangaroo Access II Enteral Feeding ContainerKNT · Traditional | 01/02/1985SE |
| K843128 | Female Urinary Incontinence SysKNX · Traditional | 01/02/1985SE |
| K843140 | Isolate Adhesive Bandage for Dry WoundNAD · Traditional | 11/08/1984SE |
Questions and answers
When was Respiradyne Ii(Tm) cleared by the FDA?
Respiradyne Ii(Tm) (K863866) received a 510(k) decision of Substantially Equivalent on January 28, 1987, 117 days after the submission was received.
What is the product code of K863866?
The FDA product code is BZK – Spirometer, Monitoring (W/Wo Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.1850.