510(k) K800087
- Device
- Ultrasonic Flowmeter
- Applicant
- THE PERKIN-ELMER CORP.
- 510(k) number
- K800087
- Product code
- BXP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-03-19
- Date received
- 1980-01-14
- Regulation
- 868.2885
- Classification name
- Transducer, Gas Flow
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3033959233
- 3005783425
- 9614485
- 3016734145
- 3018783526
- 9710567
- 1220908
- 3000126629
- 1836161
- 3016618143
- 3029871637
- 9615102
- 1722070
- 3030446844
- 3023272766
- 3011497859
- 3010370454
- 3038562397
- 3038259592
- 1924066
- 3012309966
- 3001104093
- 9611500
- 1219324
- 9617268
- 2183890
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BXP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K936141 | UNIPOWER RECHARGEABLE BATTERY PACK | Unipower Corp. | 1994-03-31 |
| K920360 | TIMOX OXYGEN TIMER | Medical Fittings, Inc. | 1992-08-03 |
| K832678 | PHONATORY FUNCTION ANALYZER PS-77 | Kells Medical, Inc. | 1984-03-07 |
| K781039 | OXY-ON DIGITAL OXYGEN TIMER | Chambers & Sadler Mfg. | 1978-08-31 |
| K770424 | OXYGEN TWMER, MODEL SST | Timeter Instrument Corp. | 1977-03-16 |
| K761260 | ARIZONA OXYGEN TIMER DEVICE | The John Bunn Co. | 1976-12-16 |