Monaghan RVM, Model 761
FDA 510(k) K884942 · Monaghan Medical Corp.
510(k) numberK884942
Submission
- Device name
- Monaghan RVM, Model 761
- Applicant
- Monaghan Medical Corp.
Plattsburgh, NY, US - Received
- November 25, 1988
- Decision date
- June 7, 1989
- 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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| K173181 | ExSpiron 1XiBZK · Traditional | Respiratory Motion, Inc. | 03/16/2018SE |
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| 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 |
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| K031514 | Modification to Trupeak Peak Flow MeterBZH · Special | 05/23/2003SE |
| K023097 | Truezone Peak Flow MeterBZH · Abbreviated | 03/07/2003SE |
| K012939 | Aerovent II CHC Collapsible Holding ChamberCAF · Special | 09/28/2001SE |
| K991212 | Modification to Truzone Peak Flow MeterBZH · Abbreviated | 07/01/1999SE |
| K964130 | Aerogear Asthma Action KitBZH · Traditional | 01/10/1997SE |
| K963089 | Truzone Peak Flow MeterBZH · Traditional | 11/06/1996SE |
| K963095 | Trupeak Peak Flow MeterBZH · Traditional | 11/04/1996SE |
Questions and answers
When was Monaghan RVM, Model 761 cleared by the FDA?
Monaghan RVM, Model 761 (K884942) received a 510(k) decision of Substantially Equivalent on June 7, 1989, 194 days after the submission was received.
What is the product code of K884942?
The FDA product code is BZK – Spirometer, Monitoring (W/Wo Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.1850.