DIGITAL MXR-D FLOWMETER
FDA 510(k) clearance K062155 · decided 2006-11-09
Clearance details
- K-number
- K062155
- Device name
- DIGITAL MXR-D FLOWMETER
- Applicant
- Porter Instrument Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-28
- Decision date
- 2006-11-09
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Porter Instrument Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bag Tee Assembly Model P1407A . An accessory to the dental flowmeter which has a connectio recall (Z-0228-2009) | Porter Instrument Co Inc | 2008-10-31 |