The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for 1st Response Disposable Manometer.
| Device ID | K961318 |
| 510k Number | K961318 |
| Device Name: | 1ST RESPONSE DISPOSABLE MANOMETER |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | Avia Toney, Rac |
| Correspondent | Avia Toney, Rac INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-05 |
| Decision Date | 1996-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019315059876 | K961318 | 000 |
| 35019315059869 | K961318 | 000 |
| 10889942314355 | K961318 | 000 |
| 10889942303953 | K961318 | 000 |
| 10889942290673 | K961318 | 000 |
| 10889942290666 | K961318 | 000 |
| 10889942290529 | K961318 | 000 |
| 10889942290512 | K961318 | 000 |
| 30351688428350 | K961318 | 000 |